Status

LIST OF REGISTERED CONFORMITY ASSESSMENT BODY (CAB)

Section 10 (1) Medical Device Act 2012 (Act 737)

Regulation 8, Medical Device Regulations 2012 (MDR 2012)

REGISTRY N0.	NAME OF CAB	EXPIRY DATE	DETAILS
MDA/CAB-001	TUV SUD (MALAYSIA) SDN. BHD.	20/11/2025	↓
MDA/CAB-002	MEDCERT MALAYSIA SDN. BHD.	20/11/2025	↓
MDA/CAB-003	SGS MALAYSIA SDN. BHD.	20/11/2025	↓
MDA/CAB-004	SIRIM QAS INTERNATIONAL SDN. BHD.	20/11/2025	↓
MDA/CAB-005	BSI SERVICES MALAYSIA SDN. BHD.	20/11/2025	↓
MDA/CAB-006	DQS CERTIFICATION (M) SDN. BHD.	10/09/2026	↓
MDA/CAB-007	TUV RHEINLAND MALAYSIA (M) SDN. BHD.	10/09/2026	↓
MDA/CAB-008	TUV NORD (M) SDN. BHD.	10/09/2026	↓
MDA/CAB-009	CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD.	11/02/2024	↓
MDA/CAB-012	CI INTERNATIONAL CERTIFICATION SDN. BHD.	24/06/2024	↓
MDA/CAB-013	KGS CERTIFICATION SDN. BHD.	11/11/2024	↓
MDA/CAB-014	DNV GL INTERNATIONAL SDN. BHD.	17/05/2025	↓
MDA/CAB-016	GENUINE DIAMOND SDN. BHD.	21/11/2024	↓
MDA/CAB-017	ITC ZENITH (M) SDN. BHD.	13/04/2023	↓
MDA/CAB-018	NEWERA INTERNATIONAL CERTIFICATION SDN. BHD.	17/12/2023	↓
MDA/CAB-019	ASI CERTIFICATION SDN. BHD.	11/11/2024	↓
MDA/CAB-020	MEDIVICE CERTIFICATION SDN. BHD.	03/04/2025	↓
MDA/CAB-021	KIWA INTERNATIONAL CERTIFICATIONS (M) SDN. BHD.	03/04/2025	↓
MDA/CAB-022	AQC TECHNICAL ASSESSORS (M) SDN BHD	16/06/2024	↓
MDA/CAB-023	NIOSH CERTIFICATION SDN. BHD	28/08/2025	↓
MDA/CAB-024	PLATINUM SHAUFFMANTZ VERITAS SDN. BHD.	14/08/2026	↓
MDA/CAB-025	LEADER CERTIFICATION SDN. BHD.	17/10/2026	↓

Note: Please click (↓) to view the details of the CAB

LIST OF REGISTERED AUDITORS AND TECHNICAL PERSONNEL

Section 10 (1) Medical Device Act 2012 (Act 737)

Regulation 8, Medical Device Regulations 2012 (MDR 2012)

1	Name of CAB: TÜV SÜD (MALAYSIA) SDN. BHD. CAB Registration Number: MDA/CAB-001 CAB Registration Period: 21/11/2022 - 20/11/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	CHEN FEZ SHIN	ISO 13485, GDPMD	VERIFICATION
2	LIM EU KENG	ISO 13485, GDPMD	-
3	NG LAI HUAT	ISO 13485, GDPMD	VERIFICATION
4	NG PUI YIAN (AMELIA)	ISO 13485, GDPMD	VERIFICATION
5	NUR RAZIFAH BINTI MOHAMAD RAZIP	ISO 13485, GDPMD	VERIFICATION
6	NURFARAHIN BINTI MOHD JOHAN	ISO 13485, GDPMD	VERIFICATION
7	NUR FARRAHIN BINTI MD ZULKIFLI FARID	ISO 13485, GDPMD	VERIFICATION
8	REENA A/P THRIUMANI (DR.)	ISO 13485, GDPMD	-
9	SAIDATUL WAHEEDA BINTI AHMAD	GDPMD	VERIFICATION
10	SOON BEE BEE (CLARISE)	ISO 13485, GDPMD	VERIFICATION
11	VINCENT LAM CHEE CHOONG	ISO 13485, GDPMD	-
12	WONG POH FUN @ WONG KAH FAH	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0107, MDS 7005, VERIFICATION
13	YAP LI CHUEN (AUDREY)	ISO 13485, GDPMD	MD 0102, MD 0301, VERIFICATION

2	Name of CAB: MEDCERT MALAYSIA SDN. BHD. CAB Registration Number: MDA/CAB-002 CAB Registration Period: 21/11/2022 - 20/11/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	BIANCHI MARKUS MARIA (MARKUS BIANCHI)	ISO 13485	MD 1111, MD 1201, MD 1202, MD 1302, MD 1402
2	FRANZKE CARSTEN PETER OTTO (CARSTEN FRANZKE)	ISO 13485	-
3	GNANA SAKARAN A/L RAJAGOPAL	GDPMD	VERIFICATION
4	LEONG FOONG KHUAN	GDPMD	VERIFICATION
5	NELLIE ONG YEE HOON	GDPMD	VERIFICATION
6	NYAN TUN OO	GDPMD	VERIFICATION
7	SIEW YEW KONG	GDPMD	VERIFICATION
8	TUNG YIN PING (CHRISTIE)	GDPMD	VERIFICATION

3	Name of CAB: SGS (MALAYSIA) SDN. BHD. CAB Registration Number: MDA/CAB-003 CAB Registration Period: 21/11/2022 - 20/11/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	CHEE SUAT KHENG	GDPMD	VERIFICATION
2	KAMARRUZAIMISHAM BIN HARUN	GDPMD	-
3	KELVIN LIM KOK WEI	ISO 13485, GDPMD	-
4	MOHD AMZAN BIN MOHAMED	GDPMD	-
5	SAMSUDDIN BIN MUSTAHKIM	ISO 13485, GDPMD	VERIFICATION
6	SAN SWEE LAN	ISO 13485, GDPMD	VERIFICATION
7	TAN KEE WOON (THOMAS)	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0105, MD 0108, MD 0204, MD 0301, MD 0303, MD 1101, VERIFICATION
8	THYAGARAJAN A/L SARAVANAMUTHU	ISO 13485, GDPMD	-
9	WONG LOKE SONG	GDPMD	-

4	Name of CAB: SIRIM QAS INTERNATIONAL SDN. BHD. CAB Registration Number: MDA/CAB-004 CAB Registration Period: 21/11/2022 - 20/11/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	ANWAR BIN ABDULLAH (DATO’)	GDPMD	VERIFICATION
2	HAM FIN LAN	ISO 13485	VERIFICATION
3	KAMINI A/P M. SOORIAMOORTHY	ISO 13485, GDPMD	MD 0107, VERIFICATION
4	MARLINI BINTI MAHADZAR	ISO 13485, GDPMD	VERIFICATION
5	MD ZAINI BIN MD JAI	ISO 13485, GDPMD	MD 0102, MD 0107, MDS 7005, VERIFICATION
6	MOHAMAD SYAFIQ BIN IDRIS	ISO 13485, GDPMD	MD 0202, MD 1101, MD 1102, MD 1104, MD 1106, MD 1107, MD 1109, MD 1111, VERIFICATION
7	MOHAMMAD AZAM BIN MUJAINI	ISO 13485, GDPMD	VERIFICATION
8	MOHD HAFIZ BIN MOHD ZAKI	ISO 13485, GDPMD	MD 0202, MD 0204, MD 0301, MD 0303, MD 0403, IVD 0404, MDS 7002, VERIFICATION
9	MOHD IZHAR BIN MOHD ZAIN	ISO 13485, GDPMD	MD 0108, VERIFICATION
10	NOR AKMANIZAM BIN FAKHRUDIN	GDPMD	-
11	NORIZAH BINTI YAHAYA	ISO 13485, GDPMD	MD 0402
12	NURUL SYAZWANI BINTI SABRAN	ISO 13485	VERIFICATION
13	SARAH BINTI NORDIN	ISO 13485, GDPMD	IVD 0203, IVD 0303, IVD 0307, IVD 0401, IVD 0405, VERIFICATION

5	Name of CAB: BSI SERVICES MALAYSIA SDN. BHD. CAB Registration Number: MDA/CAB-005 CAB Registration Period: 21/11/2022 – 20/11/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	AHMAD NIZAR BIN ABD MALIK	ISO 13485, GDPMD	VERIFICATION
2	ALAFIAH BINTI AHMED HUSAIN	ISO 13485, GDPMD	VERIFICATION
3	HAU ZHE FUNG	ISO 13485, GDPMD	MD 0101, VERIFICATION
4	LIM TUAN CHEE (IR.)	ISO 13485, GDPMD	-
5	MOHAMMAD HAFIZ ASRAF BIN MD HASHIM	ISO 13485, GDPMD	VERIFICATION
6	MUHAMAD NORSHAFIQ BIN ISMAIL	ISO 13485, GDPMD	****MD 0402, VERIFICATION
7	NORHAZIRA BINTI SHAHRIN YUSOFF	ISO 13485, GDPMD	VERIFICATION
8	RAJAKUMARAN A/L KARNAGARAN	ISO 13485, GDPMD	MD 1302, VERIFICATION
9	YIP LYE PING (JOANNE)	GDPMD	-

6	Name of CAB: DQS CERTIFICATION (M) SDN. BHD. CAB Registration Number: MDA/CAB-006 CAB Registration Period: 11/09/2023 - 10/09/2026
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	NUR KHAIRUN HANIS BINTI ABU BAKAR	ISO 13485, GDPMD	MD 0101, MD 0107, VERIFICATION
2	SHALEE RAMAKRISHNAN	ISO 13485, GDPMD	-
3	SUZAIRA BINTI YUSAK	ISO 13485, GDPMD	MD 0101, VERIFICATION

7	Name of CAB: TÜV RHEINLAND MALAYSIA SDN. BHD. CAB Registration Number: MDA/CAB-007 CAB Registration Period: 11/09/2023 - 10/09/2026
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	ABDUL RAHMAN BIN AB GHANI	ISO 13485, GDPMD	MD 0107, MDS 7005, VERIFICATION
2	LEE SIEW LYNN	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0106, MD 0202, VERIFICATION
3	QIN HUI (SAMUEL)	-	MD 0101, MD 0102, MD 0106, MD 0301, MD 0401, MD 0402, IVD 0201, IVD 0202, IVD 0203, IVD 0307, IVD 0309, IVD 0401, IVD 0403, IVD 0405, IVD 0406, VERIFICATION
4	SITI FAIRUS BINTI SAHUL HAMID	ISO 13485, GDPMD	MD 0104, MD 0108, VERIFICATION
5	SURESH KUMAR A/L MUNIANDY	ISO 13485, GDPMD	VERIFICATION

8	Name of CAB: TÜV NORD (MALAYSIA) SDN. BHD. CAB Registration Number: MDA/CAB-008 CAB Registration Period: 11/09/2023 - 10/09/2026
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	LOKE WING MUN (EDMUND)	GDPMD	MD 0106, MD 0107, MD 0108, MD 1111, MD 1301, VERIFICATION
2	MOHAMMAD GHADAFFI BIN ADMAN	GDPMD	-
3	MUHAMMAD ARIF BIN GULAM MANAVER	ISO 13485, GDPMD	VERIFICATION
4	RAZIN SAAD BIN MD NOR	GDPMD	-
5	TAN KAY HAN	GDPMD	VERIFICATION
6	TAY THAIN HOU	ISO 13485, GDPMD	-

9	Name of CAB: CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD. CAB Registration Number: MDA/CAB-009 CAB Registration Period: 12/02/2021 - 11/02/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	AZFAR BIN ALRAZI	ISO 13485, GDPMD	MD 1101, MD 1102, MD 1202, MD 1302, VERIFICATION
2	ERWAN KARTIKA BIN KATERUN	ISO 13485, GDPMD	VERIFICATION
3	HONG CHOONG MUN	ISO 13485, GDPMD	-
4	MUHAMMAD FIRDAUS BIN KHAIRUDIN	ISO 13485, GDPMD	VERIFICATION
5	NURUL NATASYA BINTI AZHARI	ISO 13485, GDPMD	VERIFICATION
6	TEO CHIN SIONG (FLEMING)	ISO 13485, GDPMD	VERIFICATION
7	TUAN MAIZUAIN AFILA BINTI TUAN MOHAMAD ZAKI	ISO 13485, GDPMD	MD 0102, VERIFICATION

10	Name of CAB: CI INTERNATIONAL CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-012 CAB Registration Period: 25/6/2021 - 24/6/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	LIAU FEI LING	GDPMD	VERIFICATION
2	OOI SOO KANG	ISO 13485, GDPMD	MD 0107, VERIFICATION

11	Name of CAB: KGS CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-013 CAB Registration Period: 12/11/2021 - 11/11/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	ALIAS BIN AHMAD	ISO 13485, GDPMD	MD 0103, MD 0104, MD 0106, VERIFICATION
2	MOOK YUN YUH	ISO 13485, GDPMD	MD 0108, IVD 0403, IVD 0404, IVD 0406, MDS 7005, VERIFICATION
3	PUVANEE A/P VELUPELAY	ISO 13485, GDPMD	VERIFICATION
4	RAMANAN A/L THANGASALVAM	ISO 13485, GDPMD	VERIFICATION

12	Name of CAB: DNV GL INTERNATIONAL SDN. BHD. CAB Registration Number: MDA/CAB-014 CAB Registration Period: 18/05/2022 - 17/05/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	HASAN ZARIN MEHR ABDOL HAMID	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0103, MD 0104, MD 0105, MD 0106, MD 0107, MD 0108, MD 0201, MD 0202, MD 0203, MD 0204, MD 0301, MD 0302, MD 0303, MD 0401, MD 0402, MD 0403, MD 1101, MD 1102, MD 1103, MD 1104, MD 1106, MD 1107, MD 1108, MD 1109, MD 1110, MD 1111, MD 1301, MD 1302, VERIFICATION
2	THILLAINATHAN A/L RAMAYA	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0105, MD 1111, VERIFICATION
3	SARALA LETCHUMY A/P RAMDAS @ RAMADASS	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0107, VERIFICATION
4	WAN AZIZUL HAFIZ BIN WAN ABDUL RAHMAN	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0104, MD 0106, MD 0108, MD 0301, MD 0302, MD 0303, VERIFICATION

13	Name of CAB: GENUINE DIAMOND SDN. BHD. CAB Registration Number: MDA/CAB-016 CAB Registration Period: 22/11/2021 - 21/11/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	AZIZAH BINTI MUHAMMAD	GDPMD	VERIFICATION
2	MOHD FARID BIN YAHAYA (DATO’ DR.)	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0104, MD 0106, MD 0107, MD 0108, MD 0301, MD 0302, MD 0303, IVD 0101, IVD 0201, IVD 0202, IVD 0203, IVD 0303, IVD 0305, IVD 0307, IVD 0401, IVD 0402, IVD 0403, IVD 0404, IVD 0405, IVD 0406, MDS 7002, MDS 7206, MDS 7210, VERIFICATION
3	NOR FAIRUS BINTI CHE SHAFEE	ISO 13485, GDPMD	VERIFICATION
4	NUR ROSMARINIE BINTI BAHAROM	GDPMD	VERIFICATION
5	NURUL AFNA BINTI ZULAMI	ISO 13485, GDPMD	VERIFICATION
6	ZAMANE BIN ABDUL RAHMAN (DATO’)	ISO 13485, GDPMD	MD 0101, MD 0102, ***MD 1101, MD 1102, MD 1103, MD 1104, MD 1105, MD 1106, MD 1107, MD 1109, MD 1201, MD 1202, MD 1301, MD 1302, VERIFICATION

14	Name of CAB: NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-018 CAB Registration Period: 18/12/2020 - 17/12/2023
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	CHAN SOKE MEI	ISO 13485, GDPMD	VERIFICATION
2	FOO SAIK KIN (JIMMY)	ISO 13485, GDPMD	-
3	PANG CHIA BOON	ISO 13485, GDPMD	MD 0103, MD 0106, MD 0202, MD 0403, VERIFICATION

15	Name of CAB: ASI CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-019 CAB Registration Period: 12/11/2021 - 11/11/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	GNANA SAKARAN A/L RAJAGOPAL	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0103, MD 0104, MD 0106, MD 1101, MD 1102, MD 1103, MD 1104, MD 1105, MD 1106, MD 1107, MD 1108, MD 1109, MD 1201, MD 1202, MD1302, MD1401, MD 1402, MD 1403, MDS 7004, MDS 7005, VERIFICATION
2	NEELANDRAN A/L MACHAPUVALIAH	ISO 13485, GDPMD	MD 0104, MD 0106, MD 0108, IVD 0309, IVD 0404, IVD 0406, MDS 7206, MDS 7210, VERIFICATION

16	Name of CAB: MEDIVICE CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-020 CAB Registration Period: 04/04/2022 - 03/04/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	ABDUL RAHMAN BIN AB GHANI	ISO 13485, GDPMD	MD 0101, MD 0102, MD 0106, MD 0107, MD 0108, MD 0301, MDS 7005, VERIFICATION
2	GOMATHI A/P RAJENDRAN	ISO 13485, GDPMD	IVD 0403, IVD 0404, IVD 0406, VERIFICATION
3	MOHD FAUZI BIN MOHD IDRIS	ISO 13485, GDPMD	IVD 0309, IVD 0405, VERIFICATION
4	NOR AKMANIZAM BIN FAKHRUDDIN	ISO 13485, GDPMD	MD 0102, MD 0104, MD 0106, MD 0301, VERIFICATION
5	NUR RUQQAYAH BINTI MOHD MAZNI	GDPMD	IVD 0305, IVD 0401, IVD 0404, IVD 0406 VERIFICATION
6	SHAH JUMAAT BIN MOHD YUSSOF (DR.)	-	MD 0301, MD 0302, MD 0303, VERIFICATION
7	SHAMILA A/P ARIARATNAM (IR.)	GDPMD	MD 0103, MD 0401, MD 1101, MD 1102, MD 1103, MD 1104, MD 1106, MD 1108, MD 1109, MD 1301, MD 1302, MD 1403, MD 1404, VERIFICATION

17	Name of CAB: KIWA INTERNATIONAL CERTIFICATIONS SDN. BHD. CAB Registration Number: MDA/CAB-021 CAB Registration Period: 04/04/2022 - 03/04/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	CHAN TEIK KEN (DR. KENNY)	ISO 13485, GDPMD	MD 0106, MD 0301, MD 0303, VERIFICATION
2	IRMALISA BINTI SAMSURI	ISO 13485, GDPMD	MD 0102, MD 0104, MD 0106, MD 0108, MD 1101, MD 1107, VERIFICATION
3	NOR AKMANIZAM BIN FAKHRUDDIN	ISO 13485, GDPMD	MD 0102, MD 0104, MD 0106, MD 0301, MD 1202, VERIFICATION
4	WAN NUR AQILAH NAJWA BINTI WAN ZAINAL ABIDIN	GDPMD	VERIFICATION

18	Name of CAB: AQC TECHNICAL ASSESSORS (M) SDN. BHD. CAB Registration Number: MDA/CAB-022 CAB Registration Period: 17/06//2021-16/06/2024
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	RAJA SEGAR A/L THANNIMALAI	ISO 13485, GDPMD	-
2	KUPPUSAMY SITHANANDHAN	ISO 13485, GDPMD	MD 0103, MD 0104, MD 0108, MD 0301, MD 1102, MD 1103, MD 1108, MD 1109, MD 1402, VERIFICATION
3	HABIB MOHAMED ASLAM	-	IVD 010, IVD 0102, IVD 0103, IVD 0201, IVD 0203, IVD 0301, IVD 0305, IVD 0307, IVD 0309, IVD 0401, IVD 0402, IVD 0403, IVD 0406

19	Name of CAB: NIOSH CERTIFICATION SDN BHD CAB Registration Number: MDA/CAB-023 CAB Registration Period: 30/08/2022 - 29/08/2025
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	NOR LIZA BT SADREK	GDPMD	VERIFICATION
2	NOR AKMANIZAM BIN FAKHRUDIN	ISO 13485, GDPMD	MD 0301, VERIFICATION

20	Name of CAB: PLATINUM SHAUFFMANTZ VERITAS SDN. BHD. CAB Registration Number: MDA/CAB-024 CAB Registration Period: 15/08/2023 - 14/08/2026
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	AMIRUL LODFI BIN AHMAD LODFI	GDPMD	MD 0106, VERIFICATION
2	NOR AKMANIZAM BIN FAKHRUDIN	GDPMD	MD 0106, MD 0301, VERIFICATION
3	SYAJARATUL NUR BINTI KAMAL	ISO 13485, GDPMD	VERIFICATION

21	Name of CAB: LEADER CERTIFICATION SDN. BHD. CAB Registration Number: MDA/CAB-025 CAB Registration Period: 18/10/2023 - 17/10/2026
No.	Auditor / Technical Personnel	QMS Scope	Technical Areas Scope
1	MUHAMMAD DANIEL MANAF BIN ISHA	ISO 13485, GDPMD	MD 0103, MD 0106, MD 0202, MD 0203, VERIFICATION
2	RADZI BIN RAHMAT	ISO 13485, GDPMD	-

Note:

(1) Blue-in-colour font means ‘new updated information’.

(2) Strikethrough font means ‘resigned personnel’.

(3) * means ‘must be accompanied with a technical expert in order to perform conformity assessment’.

(4) ** means approval only for conformity assessment on aesthetics medical devices.

(5) *** means approval only for conformity assessment on infusion medical devices.

(6) **** means approval only for conformity assessment on dental dam.

For more inquiries, please contact us:

CAB Registration Unit
Medical Device Authority

Ministry of Health Malaysia
Aras 5 & 6, Prima 9, Prima Avenue II,
Blok 3547, Persiaran APEC,
63000 Cyberjaya, Selangor

Tel: +603 8230 0356 (Mr. Fadhullah) / +603 8230 0372 (Pn. Remee)
Fax: +603 8230 0200
Email:

Updated: 2 November 2023

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