Notified Body
NB 0413
🇸🇪 Sweden
INTERTEK SEMKO AB
Torshamnsgatan 43 Box 1103, 16422 KISTA, Sweden
View on EUDAMED
Updated Oct 1, 2021
Certificates
48
Valid
0
Expiring < 6mo
1
Expired
43
Basic UDI-DIs
829
Devices
829
Manufacturers
34
Cert. Types
4
Basic Information
- Address
- Torshamnsgatan 43 Box 1103, 16422 KISTA, Sweden
- [email protected]
- Phone
- 46 8 750 01 68
Regulatory Overview
Regulation
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Eu Mdd
829
Classification
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Eu Md Class 2b
545
Eu Md Class 2a
250
Eu Md Class 1
28
Eu Md Class 3
6
Device Types
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Certificate Health
Total
48
Valid
0
Expiring < 6mo
1
Expired / Withdrawn
43
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41377505-00 | MicroSurgical Technology Inc. | Dec 11, 2022 | |||
| MDD Annex II (excluding section 4) | 41311197-02_Rev.2 | Invivo, a division of Philips Medical Systems | Jun 20, 2023 | |||
| MDD Annex II (excluding section 4) | 41377454 | Zirc Dental Products Inc. | Sep 26, 2023 | |||
| MDD Annex III | 0106415 | Nanjing 3H Medical Products Co.,Ltd. | Oct 18, 2023 | |||
| MDD Annex II (excluding section 4) | 41312638-02 | Nidek Medical Products Inc. | Oct 22, 2023 | |||
| MDD Annex II (excluding section 4) | 41312638 | Nidek Medical Products Inc. | Oct 22, 2023 | |||
| MDD Annex II (excluding section 4) | 41377776-04 | Spectra Medical Devices, LLC | Oct 24, 2023 | |||
| MDD Annex V | 41371231-03 | Shenzhen Homed Medical Device Co., Ltd. | Jan 21, 2024 | |||
| MDD Annex II Section 4 | 41312969-01 | Sonomed, Inc. | Feb 02, 2024 | |||
| MDD Annex II Section 4 | 41319383-02 | Medviso AB | Mar 06, 2024 | |||
| MDD Annex II (excluding section 4) | 41314564 | NxStage Medical, Inc. | Apr 04, 2024 | |||
| MDD Annex II (excluding section 4) | 41314564 | NxStage Medical, Inc. | Apr 04, 2024 | |||
| MDD Annex II (excluding section 4) | 413141564 | NxStage Medical, Inc. | Apr 04, 2024 | |||
| MDD Annex II (excluding section 4) | 41371240 | X-Nav Technologies, LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371410 | Remote Diagnostic Technologies Ltd. | May 26, 2024 | |||
| MDD Annex V | 41315556 | Foshan Gaunying Electronics Co., Ltd. | May 26, 2024 | |||
| MDD Annex V | 41376989-01 | InGeneron Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41313720 | Hermes Medical Solutions AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41314634 | BRAEBON Medical Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41344634 | BRAEBON Medical Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 4130113389 | TLA Targeted Immunotherapies AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41314934-05 | NorthEast Monitoring, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 4130113937-01 | Footmender AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41376877-01 | MorTan, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41315215 | Nova Eye, Inc. | May 26, 2024 | |||
| MDD Annex V | 4130112942 | Performance Health International LTD | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371240-03 | X-Nav Technologies, LLC | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41318460-04 | Medicvent AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371473-04 | Shenzhen Kentro Medical Electronics CO.,LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371473-04 | Shenzhen Kentro Medical Electronics CO.,LTD. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41376908 | Interrad Medical, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41276908 | Interrad Medical, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41377748-01 | American Surgical Company, LLC | May 26, 2024 | |||
| MDD Annex II Section 4 | 41377747-01 | American Surgical Company, LLC | May 26, 2024 | |||
| MDD Annex V | 413112298 | Biocomma Limited | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371470-03 | Shenzhen Fitfaith Technology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 4371470-03 | Shenzhen Fitfaith Technology Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41302127-00 | Eyenuk, Inc. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 413106295 | Pressure Products Medical Device Manufacturing LLC. | May 26, 2024 | |||
| MDD Annex II Section 4 | 413106296 | Pressure Products Medical Device Manufacturing LLC. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41319433-05 | Cynosure LLC | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | 41319433-05 | Cynosure LLC | May 27, 2024 | |||
| MDD Annex V | 41371607-02 | AccuTech Medical Technologies Inc. | May 27, 2024 | |||
| MDD Annex III | 0106415-03 | Nanjing 3H Medical Products Co.,Ltd. | Oct 18, 2026 | |||
| MDD Annex II (excluding section 4) | 41377383 | OsteoCare Implant System Limited | Dec 31, 2028 | |||
| MDD Annex V | 41371231 | Shenzhen Homed Medical Device Co., Ltd. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | 41313861 | Diagnosys LLC | Dec 31, 2028 | |||
| MDD Annex II Section 4 | 41343861 | Diagnosys LLC | Dec 31, 2028 |