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25.09.2026 15:37

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3412 certificate results listed.

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V13 066267 0039

Eurospital Spa

Quality management systemIssued

Certificate number: V13 066267 0039
Certificate type: Quality management system
Status: Issued
Actor: Eurospital Spa
Actor SRN: IT-MF-000028468
Notified body number: 0123
Notified body actor SRN: -
Issue date: 28.05.2026 03:00
Validity start: 28.05.2026 03:00
Validity end: 03.04.2027 03:00
Latest version: Yes

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V13 066267 0039 Rev. 00

Eurospital Spa

Quality management systemIssued

Certificate number: V13 066267 0039 Rev. 00
Certificate type: Quality management system
Status: Issued
Actor: Eurospital Spa
Actor SRN: IT-MF-000028468
Notified body number: 0123
Notified body actor SRN: -
Issue date: 28.05.2026 03:00
Validity start: 28.05.2026 03:00
Validity end: 03.04.2027 03:00
Latest version: Yes

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V13 090700 0058

i-SENS, Inc.

Quality management systemSupplemented

Certificate number: V13 090700 0058
Certificate type: Quality management system
Status: Supplemented
Actor: i-SENS, Inc.
Actor SRN: KR-MF-000009173
Notified body number: 0123
Notified body actor SRN: -
Issue date: 25.02.2026 03:00
Validity start: 25.02.2026 03:00
Validity end: 28.11.2028 03:00
Latest version: Yes

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V13 097027 0013

Hangzhou Singclean Medical Products Co., Ltd.

Quality management systemIssued

Certificate number: V13 097027 0013
Certificate type: Quality management system
Status: Issued
Actor: Hangzhou Singclean Medical Products Co., Ltd.
Actor SRN: CN-MF-000014098
Notified body number: 0123
Notified body actor SRN: -
Issue date: 10.06.2026 03:00
Validity start: 10.06.2026 03:00
Validity end: 23.04.2029 03:00
Latest version: Yes

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MDR 761832

Tandem Diabetes Care, Inc.

Technical documentationSupplemented

Certificate number: MDR 761832
Certificate type: Technical documentation
Status: Supplemented
Actor: Tandem Diabetes Care, Inc.
Actor SRN: US-MF-000031791
Notified body number: 2797
Notified body actor SRN: -
Issue date: 01.06.2026 03:00
Validity start: 01.06.2026 03:00
Validity end: 31.08.2030 03:00
Latest version: Yes

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M.2023.MDR1010

LMECA Co. Ltd.

Quality management systemWithdrawn

Certificate number: M.2023.MDR1010
Certificate type: Quality management system
Status: Withdrawn
Actor: LMECA Co. Ltd.
Actor SRN: KR-MF-000016971
Notified body number: 2696
Notified body actor SRN: -
Issue date: 02.01.2023 03:00
Validity start: 02.01.2023 03:00
Validity end: 01.01.2028 03:00
Latest version: Yes

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SCAR-6.2.1.3

Flok Health Ltd

Quality management systemAmended

Certificate number: SCAR-6.2.1.3
Certificate type: Quality management system
Status: Amended
Actor: Flok Health Ltd
Actor SRN: UK-MF-000047133
Notified body number: 3022
Notified body actor SRN: -
Issue date: 10.06.2026 03:00
Validity start: 10.06.2026 03:00
Validity end: 06.08.2030 03:00
Latest version: Yes

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MDR.2292-2026/0015

Shanghai InnoMed Technologies Inc. Ltd.

Technical documentationIssued

Certificate number: MDR.2292-2026/0015
Certificate type: Technical documentation
Status: Issued
Actor: Shanghai InnoMed Technologies Inc. Ltd.
Actor SRN: CN-MF-000039525
Notified body number: 2292
Notified body actor SRN: -
Issue date: 08.04.2026 03:00
Validity start: 08.04.2026 03:00
Validity end: 07.04.2031 03:00
Latest version: Yes

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MDR.2292-2026/0024

Hangzhou Singclean Medical Products Co., Ltd.

Technical documentationIssued

Certificate number: MDR.2292-2026/0024
Certificate type: Technical documentation
Status: Issued
Actor: Hangzhou Singclean Medical Products Co., Ltd.
Actor SRN: CN-MF-000014098
Notified body number: 2292
Notified body actor SRN: -
Issue date: 15.05.2026 03:00
Validity start: 15.05.2026 03:00
Validity end: 14.05.2031 03:00
Latest version: Yes

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MDR.2292-2026/0025

QEF MEDİKAL ANONİM ŞİRKETİ

Quality assuranceIssued

Certificate number: MDR.2292-2026/0025
Certificate type: Quality assurance
Status: Issued
Actor: QEF MEDİKAL ANONİM ŞİRKETİ
Actor SRN: TR-MF-000051382
Notified body number: 2292
Notified body actor SRN: -
Issue date: 04.06.2026 03:00
Validity start: 04.06.2026 03:00
Validity end: 03.06.2031 03:00
Latest version: Yes

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MDR.2292-2026/0026

ABFEN FARMA İLAÇ SAN. VE TİC. A.Ş.

Quality assuranceIssued

Certificate number: MDR.2292-2026/0026
Certificate type: Quality assurance
Status: Issued
Actor: ABFEN FARMA İLAÇ SAN. VE TİC. A.Ş.
Actor SRN: TR-MF-000042203
Notified body number: 2292
Notified body actor SRN: -
Issue date: 05.06.2026 03:00
Validity start: 05.06.2026 03:00
Validity end: 04.06.2031 03:00
Latest version: Yes

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IX 2631406-2

GenBody Inc.

Technical documentationIssued

Certificate number: IX 2631406-2
Certificate type: Technical documentation
Status: Issued
Actor: GenBody Inc.
Actor SRN: KR-MF-000043626
Notified body number: 0197
Notified body actor SRN: -
Issue date: 11.05.2026 03:00
Validity start: 11.05.2026 03:00
Validity end: 10.05.2031 03:00
Latest version: Yes

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IT344983

TECHNOLOGY S.R.L.

Quality management systemSupplemented

Certificate number: IT344983
Certificate type: Quality management system
Status: Supplemented
Actor: TECHNOLOGY S.R.L.
Actor SRN: IT-MF-000035728
Notified body number: 1370
Notified body actor SRN: -
Issue date: 15.04.2026 03:00
Validity start: 15.04.2026 03:00
Validity end: 06.08.2030 03:00
Latest version: Yes

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IT349382

GIMA SPA

Quality assuranceIssued

Certificate number: IT349382
Certificate type: Quality assurance
Status: Issued
Actor: GIMA SPA
Actor SRN: IT-MF-000011004
Notified body number: 1370
Notified body actor SRN: -
Issue date: 27.01.2026 03:00
Validity start: 27.01.2026 03:00
Validity end: 26.01.2031 03:00
Latest version: Yes

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IT350995-1

Panestetic S.R.L.

Quality management systemIssued

Certificate number: IT350995-1
Certificate type: Quality management system
Status: Issued
Actor: Panestetic S.R.L.
Actor SRN: IT-MF-000028477
Notified body number: 1370
Notified body actor SRN: -
Issue date: 18.03.2026 03:00
Validity start: 18.03.2026 03:00
Validity end: 17.03.2031 03:00
Latest version: Yes

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IT351643

IROMED GROUP S.R.L.

Quality management systemIssued

Certificate number: IT351643
Certificate type: Quality management system
Status: Issued
Actor: IROMED GROUP S.R.L.
Actor SRN: IT-MF-000031267
Notified body number: 1370
Notified body actor SRN: -
Issue date: 14.04.2026 03:00
Validity start: 14.04.2026 03:00
Validity end: 13.04.2031 03:00
Latest version: Yes

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IT351984

Jiangsu Sunride Medical Technology Co., Ltd.

Quality management systemIssued

Certificate number: IT351984
Certificate type: Quality management system
Status: Issued
Actor: Jiangsu Sunride Medical Technology Co., Ltd.
Actor SRN: CN-MF-000040642
Notified body number: 1370
Notified body actor SRN: -
Issue date: 27.04.2026 03:00
Validity start: 27.04.2026 03:00
Validity end: 26.04.2031 03:00
Latest version: Yes

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IT352911

DeepTrace Technologies S.R.L.

Quality management systemIssued

Certificate number: IT352911
Certificate type: Quality management system
Status: Issued
Actor: DeepTrace Technologies S.R.L.
Actor SRN: IT-MF-000027591
Notified body number: 1370
Notified body actor SRN: -
Issue date: 22.05.2026 03:00
Validity start: 22.05.2026 03:00
Validity end: 21.05.2031 03:00
Latest version: Yes

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IT353035

DENTIS CO., LTD

Quality management systemIssued

Certificate number: IT353035
Certificate type: Quality management system
Status: Issued
Actor: DENTIS CO., LTD
Actor SRN: KR-MF-000012523
Notified body number: 1370
Notified body actor SRN: -
Issue date: 26.05.2026 03:00
Validity start: 26.05.2026 03:00
Validity end: 25.05.2031 03:00
Latest version: Yes

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024-00-02-MDR

ANGIOLOGICA B.M. S.R.L.

Quality management systemSupplemented

Certificate number: 024-00-02-MDR
Certificate type: Quality management system
Status: Supplemented
Actor: ANGIOLOGICA B.M. S.R.L.
Actor SRN: IT-MF-000030846
Notified body number: 0426
Notified body actor SRN: -
Issue date: 04.06.2026 03:00
Validity start: 04.06.2026 03:00
Validity end: 05.07.2028 03:00
Latest version: Yes

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