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24.09.2026 14:57

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M.2025.MDR.1078

Shunmei Medical Co.,Ltd

Quality management systemAmended

Certificate number: M.2025.MDR.1078
Certificate type: Quality management system
Status: Amended
Actor: Shunmei Medical Co.,Ltd
Actor SRN: CN-MF-000001160
Notified body number: 2696
Notified body actor SRN: -
Issue date: 02.07.2026 03:00
Validity start: 02.07.2026 03:00
Validity end: 15.05.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 723819

Synaptive Medical Inc.

Quality management systemReissued

Certificate number: MDR 723819
Certificate type: Quality management system
Status: Reissued
Actor: Synaptive Medical Inc.
Actor SRN: CA-MF-000010705
Notified body number: 2797
Notified body actor SRN: -
Issue date: 11.06.2026 03:00
Validity start: 17.06.2026 03:00
Validity end: 16.06.2031 03:00
Latest version: Yes

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Related devices Manufacturer

IVDR 739320

Leica Biosystems Newcastle Ltd

Quality management systemReissued

Certificate number: IVDR 739320
Certificate type: Quality management system
Status: Reissued
Actor: Leica Biosystems Newcastle Ltd
Actor SRN: GB-MF-000020595
Notified body number: 2797
Notified body actor SRN: -
Issue date: 01.06.2026 03:00
Validity start: 08.06.2026 03:00
Validity end: 07.06.2031 03:00
Latest version: Yes

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Related devices Manufacturer

IVDR 795087

SML Genetree Co., Ltd.

Quality management systemSupplemented

Certificate number: IVDR 795087
Certificate type: Quality management system
Status: Supplemented
Actor: SML Genetree Co., Ltd.
Actor SRN: KR-MF-000034755
Notified body number: 2797
Notified body actor SRN: -
Issue date: 02.06.2026 03:00
Validity start: 02.06.2026 03:00
Validity end: 18.05.2030 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 719658

Ethicon, LLC.

Technical documentationSupplemented

Certificate number: MDR 719658
Certificate type: Technical documentation
Status: Supplemented
Actor: Ethicon, LLC.
Actor SRN: US-MF-000013111
Notified body number: 2797
Notified body actor SRN: -
Issue date: 05.06.2026 03:00
Validity start: 05.06.2026 03:00
Validity end: 04.07.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 730051

Johnson & Johnson International

Technical documentationSupplemented

Certificate number: MDR 730051
Certificate type: Technical documentation
Status: Supplemented
Actor: Johnson & Johnson International
Actor SRN: BE-MF-000008018
Notified body number: 2797
Notified body actor SRN: -
Issue date: 05.06.2026 03:00
Validity start: 05.06.2026 03:00
Validity end: 29.05.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 742901

Geuder AG

Quality management systemSupplemented

Certificate number: MDR 742901
Certificate type: Quality management system
Status: Supplemented
Actor: Geuder AG
Actor SRN: DE-MF-000008044
Notified body number: 2797
Notified body actor SRN: -
Issue date: 01.06.2026 03:00
Validity start: 01.06.2026 03:00
Validity end: 18.07.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 755931

Regen Lab SA

Quality management systemSupplemented

Certificate number: MDR 755931
Certificate type: Quality management system
Status: Supplemented
Actor: Regen Lab SA
Actor SRN: CH-MF-000032231
Notified body number: 2797
Notified body actor SRN: -
Issue date: 15.06.2026 03:00
Validity start: 15.06.2026 03:00
Validity end: 24.04.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 756198

Regen Lab SA

Technical documentationSupplemented

Certificate number: MDR 756198
Certificate type: Technical documentation
Status: Supplemented
Actor: Regen Lab SA
Actor SRN: CH-MF-000032231
Notified body number: 2797
Notified body actor SRN: -
Issue date: 15.06.2026 03:00
Validity start: 15.06.2026 03:00
Validity end: 24.04.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 756199

Regen Lab SA

Technical documentationSupplemented

Certificate number: MDR 756199
Certificate type: Technical documentation
Status: Supplemented
Actor: Regen Lab SA
Actor SRN: CH-MF-000032231
Notified body number: 2797
Notified body actor SRN: -
Issue date: 15.06.2026 03:00
Validity start: 15.06.2026 03:00
Validity end: 24.04.2028 03:00
Latest version: Yes

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Related devices Manufacturer

M.2025.MDR.2018

Zhejiang Barty Medical Technology Co., Ltd.

Technical documentationAmended

Certificate number: M.2025.MDR.2018
Certificate type: Technical documentation
Status: Amended
Actor: Zhejiang Barty Medical Technology Co., Ltd.
Actor SRN: CN-MF-000007977
Notified body number: 2696
Notified body actor SRN: -
Issue date: 22.06.2026 03:00
Validity start: 22.06.2026 03:00
Validity end: 14.05.2028 03:00
Latest version: Yes

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Related devices Manufacturer

V13 099231 0006

Precision Biosensor Inc.

Quality management systemIssued

Certificate number: V13 099231 0006
Certificate type: Quality management system
Status: Issued
Actor: Precision Biosensor Inc.
Actor SRN: KR-MF-000034861
Notified body number: 0123
Notified body actor SRN: -
Issue date: 22.06.2026 03:00
Validity start: 22.06.2026 03:00
Validity end: 21.06.2031 03:00
Latest version: Yes

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Related devices Manufacturer

TW23/00000626

ONBO Electronic (Shenzhen) Co., Ltd.

Quality management systemSupplemented

Certificate number: TW23/00000626
Certificate type: Quality management system
Status: Supplemented
Actor: ONBO Electronic (Shenzhen) Co., Ltd.
Actor SRN: CN-MF-000013782
Notified body number: 1639
Notified body actor SRN: -
Issue date: 11.06.2026 03:00
Validity start: 11.06.2026 03:00
Validity end: 24.08.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 719650

Ethicon, LLC.

Technical documentationSupplemented

Certificate number: MDR 719650
Certificate type: Technical documentation
Status: Supplemented
Actor: Ethicon, LLC.
Actor SRN: US-MF-000013111
Notified body number: 2797
Notified body actor SRN: -
Issue date: 05.06.2026 03:00
Validity start: 05.06.2026 03:00
Validity end: 04.07.2028 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 730827

Medtronic, Inc.

Quality management systemReissued

Certificate number: MDR 730827
Certificate type: Quality management system
Status: Reissued
Actor: Medtronic, Inc.
Actor SRN: US-MF-000019977
Notified body number: 2797
Notified body actor SRN: -
Issue date: 04.06.2026 03:00
Validity start: 20.07.2026 03:00
Validity end: 19.07.2031 03:00
Latest version: Yes

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Related devices Manufacturer

TD745.059

CVRx, Inc.

Technical documentationIssued

Certificate number: TD745.059
Certificate type: Technical documentation
Status: Issued
Actor: CVRx, Inc.
Actor SRN: US-MF-000001082
Notified body number: 0050
Notified body actor SRN: -
Issue date: 30.06.2026 03:00
Validity start: 30.06.2026 03:00
Validity end: 08.04.2030 03:00
Latest version: Yes

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Related devices Manufacturer

M.2025.MDR.1064

Henan Tuoren Kingtaek Medical Device Co., Ltd.

Quality management systemCancelled

Certificate number: M.2025.MDR.1064
Certificate type: Quality management system
Status: Cancelled
Actor: Henan Tuoren Kingtaek Medical Device Co., Ltd.
Actor SRN: CN-MF-000015021
Notified body number: 2696
Notified body actor SRN: -
Issue date: 26.02.2025 03:00
Validity start: 26.02.2025 03:00
Validity end: 25.02.2030 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 768180

CooperSurgical, Inc.

Technical documentationSupplemented

Certificate number: MDR 768180
Certificate type: Technical documentation
Status: Supplemented
Actor: CooperSurgical, Inc.
Actor SRN: US-MF-000002607
Notified body number: 2797
Notified body actor SRN: -
Issue date: 08.06.2026 03:00
Validity start: 08.06.2026 03:00
Validity end: 07.01.2030 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 768181

CooperSurgical, Inc.

Technical documentationSupplemented

Certificate number: MDR 768181
Certificate type: Technical documentation
Status: Supplemented
Actor: CooperSurgical, Inc.
Actor SRN: US-MF-000002607
Notified body number: 2797
Notified body actor SRN: -
Issue date: 08.06.2026 03:00
Validity start: 08.06.2026 03:00
Validity end: 24.09.2029 03:00
Latest version: Yes

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Related devices Manufacturer

MDR 00114-A

Global D

Quality management systemIssued

Certificate number: MDR 00114-A
Certificate type: Quality management system
Status: Issued
Actor: Global D
Actor SRN: FR-MF-000024267
Notified body number: 0476
Notified body actor SRN: -
Issue date: 24.04.2026 03:00
Validity start: 24.04.2026 03:00
Validity end: 02.12.2030 03:00
Latest version: Yes

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