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08.07.2026 23:18

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3056

3056 certificate results listed.

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HZ 2241408-1

GE Medical Systems LLC

Quality management systemReissued

Certificate number: HZ 2241408-1
Certificate type: Quality management system
Status: Reissued
Actor: GE Medical Systems LLC
Actor SRN: US-MF-000001632
Notified body number: 0197
Notified body actor SRN: -
Issue date: 26.06.2025 03:00
Validity start: 02.07.2025 03:00
Validity end: 01.07.2030 03:00
Latest version: Yes

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HZ 2241427-1

GE Medical Systems Israel", Functional Imaging

Quality management systemSupplemented

Certificate number: HZ 2241427-1
Certificate type: Quality management system
Status: Supplemented
Actor: GE Medical Systems Israel", Functional Imaging
Actor SRN: IL-MF-000003062
Notified body number: 0197
Notified body actor SRN: -
Issue date: 14.05.2026 03:00
Validity start: 14.05.2026 03:00
Validity end: 19.09.2027 03:00
Latest version: Yes

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HZ 2247538-1

Stryker Instruments

Quality management systemSupplemented

Certificate number: HZ 2247538-1
Certificate type: Quality management system
Status: Supplemented
Actor: Stryker Instruments
Actor SRN: US-MF-000025219
Notified body number: 0197
Notified body actor SRN: -
Issue date: 12.05.2026 03:00
Validity start: 12.05.2026 03:00
Validity end: 27.02.2031 03:00
Latest version: Yes

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HZ 2343812-1

Shenzhen MandeLab Co., Ltd.

Quality management systemIssued

Certificate number: HZ 2343812-1
Certificate type: Quality management system
Status: Issued
Actor: Shenzhen MandeLab Co., Ltd.
Actor SRN: CN-MF-000009021
Notified body number: 0197
Notified body actor SRN: -
Issue date: 22.08.2024 03:00
Validity start: 22.08.2024 03:00
Validity end: 16.03.2027 03:00
Latest version: Yes

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HZ 2367770-1

Shenzhen Root Innovation Technology Co., Ltd.

Quality management systemIssued

Certificate number: HZ 2367770-1
Certificate type: Quality management system
Status: Issued
Actor: Shenzhen Root Innovation Technology Co., Ltd.
Actor SRN: CN-MF-000035094
Notified body number: 0197
Notified body actor SRN: -
Issue date: 28.05.2026 03:00
Validity start: 28.05.2026 03:00
Validity end: 27.05.2031 03:00
Latest version: Yes

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HZ 2467727-1

Guilin Kevin Peter Technology Co., Ltd.

Quality management systemReissued

Certificate number: HZ 2467727-1
Certificate type: Quality management system
Status: Reissued
Actor: Guilin Kevin Peter Technology Co., Ltd.
Actor SRN: CN-MF-000022934
Notified body number: 0197
Notified body actor SRN: -
Issue date: 02.02.2026 03:00
Validity start: 02.02.2026 03:00
Validity end: 23.01.2030 03:00
Latest version: Yes

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HZ 2678802-1

bitop AG

Quality management systemReissued

Certificate number: HZ 2678802-1
Certificate type: Quality management system
Status: Reissued
Actor: bitop AG
Actor SRN: DE-MF-000006543
Notified body number: 0197
Notified body actor SRN: -
Issue date: 01.06.2026 03:00
Validity start: 01.06.2026 03:00
Validity end: 26.02.2029 03:00
Latest version: Yes

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HZ 2693790-1

GA Health Company Limited

Quality management systemIssued

Certificate number: HZ 2693790-1
Certificate type: Quality management system
Status: Issued
Actor: GA Health Company Limited
Actor SRN: HK-MF-000019784
Notified body number: 0197
Notified body actor SRN: -
Issue date: 02.06.2026 03:00
Validity start: 02.06.2026 03:00
Validity end: 01.06.2031 03:00
Latest version: Yes

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HZ 2709727-1

Hemolens Diagnostics Sp. z o.o.

Quality management systemIssued

Certificate number: HZ 2709727-1
Certificate type: Quality management system
Status: Issued
Actor: Hemolens Diagnostics Sp. z o.o.
Actor SRN: PL-MF-000016015
Notified body number: 0197
Notified body actor SRN: -
Issue date: 21.05.2026 03:00
Validity start: 21.05.2026 03:00
Validity end: 20.05.2031 03:00
Latest version: Yes

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IT321284

GPI S.P.A.

Quality management systemReissued

Certificate number: IT321284
Certificate type: Quality management system
Status: Reissued
Actor: GPI S.P.A.
Actor SRN: IT-MF-000020127
Notified body number: 1370
Notified body actor SRN: -
Issue date: 23.02.2023 03:00
Validity start: 23.02.2023 03:00
Validity end: 22.02.2028 03:00
Latest version: Yes

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IT342456

ALMA s.r.l.

Quality assuranceIssued

Certificate number: IT342456
Certificate type: Quality assurance
Status: Issued
Actor: ALMA s.r.l.
Actor SRN: IT-MF-000029690
Notified body number: 1370
Notified body actor SRN: -
Issue date: 06.11.2025 03:00
Validity start: 06.11.2025 03:00
Validity end: 11.05.2030 03:00
Latest version: Yes

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SCAR-9.2.1.4

Tandem Health AB

Quality management systemSupplemented

Certificate number: SCAR-9.2.1.4
Certificate type: Quality management system
Status: Supplemented
Actor: Tandem Health AB
Actor SRN: SE-MF-000049463
Notified body number: 3022
Notified body actor SRN: -
Issue date: 05.06.2026 03:00
Validity start: 05.06.2026 03:00
Validity end: 15.02.2031 03:00
Latest version: Yes

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SCAR-21.2.1.0

BrightHeart

Quality management systemIssued

Certificate number: SCAR-21.2.1.0
Certificate type: Quality management system
Status: Issued
Actor: BrightHeart
Actor SRN: FR-MF-000044855
Notified body number: 3022
Notified body actor SRN: -
Issue date: 02.06.2026 03:00
Validity start: 02.06.2026 03:00
Validity end: 01.06.2031 03:00
Latest version: Yes

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MDR 00064-B

Noventure S.L.U.

Technical documentationIssued

Certificate number: MDR 00064-B
Certificate type: Technical documentation
Status: Issued
Actor: Noventure S.L.U.
Actor SRN: ES-MF-000000797
Notified body number: 0476
Notified body actor SRN: -
Issue date: 27.03.2025 03:00
Validity start: 27.03.2025 03:00
Validity end: 14.11.2029 03:00
Latest version: Yes

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MDR 00064-C

Noventure S.L.U.

Quality management systemIssued

Certificate number: MDR 00064-C
Certificate type: Quality management system
Status: Issued
Actor: Noventure S.L.U.
Actor SRN: ES-MF-000000797
Notified body number: 0476
Notified body actor SRN: -
Issue date: 15.11.2024 03:00
Validity start: 15.11.2024 03:00
Validity end: 14.11.2029 03:00
Latest version: Yes

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ITH 1343248 1

Hydra srl

Quality management systemSupplemented

Certificate number: ITH 1343248 1
Certificate type: Quality management system
Status: Supplemented
Actor: Hydra srl
Actor SRN: IT-MF-000029149
Notified body number: 1936
Notified body actor SRN: -
Issue date: 08.05.2026 03:00
Validity start: 08.05.2026 03:00
Validity end: 02.02.2028 03:00
Latest version: Yes

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M.2025.MDR.1068

Shandong Weigao Orthopaedic Device Company Limited.

Quality management systemAmended

Certificate number: M.2025.MDR.1068
Certificate type: Quality management system
Status: Amended
Actor: Shandong Weigao Orthopaedic Device Company Limited.
Actor SRN: CN-MF-000019785
Notified body number: 2696
Notified body actor SRN: -
Issue date: 22.05.2026 03:00
Validity start: 22.05.2026 03:00
Validity end: 07.04.2028 03:00
Latest version: Yes

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M.2025.MDR.1069

Zhejiang Soudon Medical Technology Co.,Ltd

Quality management systemSupplemented

Certificate number: M.2025.MDR.1069
Certificate type: Quality management system
Status: Supplemented
Actor: Zhejiang Soudon Medical Technology Co.,Ltd
Actor SRN: CN-MF-000021047
Notified body number: 2696
Notified body actor SRN: -
Issue date: 18.05.2026 03:00
Validity start: 18.05.2026 03:00
Validity end: 07.04.2029 03:00
Latest version: Yes

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M.2025.MDR.1070

Zhejiang Soudon Medical Technology Co.,Ltd

Quality management systemWithdrawn

Certificate number: M.2025.MDR.1070
Certificate type: Quality management system
Status: Withdrawn
Actor: Zhejiang Soudon Medical Technology Co.,Ltd
Actor SRN: CN-MF-000021047
Notified body number: 2696
Notified body actor SRN: -
Issue date: 08.04.2025 03:00
Validity start: 08.04.2025 03:00
Validity end: 07.04.2030 03:00
Latest version: Yes

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M.2025.MDR.1079

Shunmei Medical Co.,Ltd

Quality management systemWithdrawn

Certificate number: M.2025.MDR.1079
Certificate type: Quality management system
Status: Withdrawn
Actor: Shunmei Medical Co.,Ltd
Actor SRN: CN-MF-000001160
Notified body number: 2696
Notified body actor SRN: -
Issue date: 16.05.2025 03:00
Validity start: 16.05.2025 03:00
Validity end: 15.05.2029 03:00
Latest version: Yes

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