Notified Body
NB 0598
🇫🇮 Finland
SGS FIMKO OY
Takomotie 8, 00380 HELSINKI, Finland
View on EUDAMED
Updated Oct 2, 2021
Certificates
23
Valid
19
Expiring < 6mo
1
Expired
4
Basic UDI-DIs
0
Devices
0
Manufacturers
23
Cert. Types
1
Basic Information
- Address
- Takomotie 8, 00380 HELSINKI, Finland
- [email protected]
- Phone
- +358 9 696 361
- Website
- www.sgs.fi
Certificate Health
Total
23
Valid
19
Expiring < 6mo
1
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDR QMS | FI22/871878 | Combinostics Oy | MDR | May 2024 | May 07, 2025 | Supplemented |
| MDR QMS | FI23/0000008 | Shenzhen Dongdixin Technology Co., Ltd. | MDR | May 2023 | Mar 20, 2026 | Supplemented |
| MDR QMS | FI23/00000013 | Gründler GmbH | MDR | Mar 2023 | Mar 30, 2026 | Issued |
| MDR QMS | FI20/00000020 | Disior Oy | MDR | May 2023 | May 30, 2026 | Issued |
| MDR QMS | FI23/00000046 | Rhyk Technologies GmbH | MDR | Sep 2023 | Sep 26, 2026 | Issued |
| MDR QMS | FI23/0000004 | Planmed Oy | MDR | Feb 2024 | Jan 23, 2027 | Supplemented |
| MDR QMS | FI24/00000055 | Vitec Codea Oy | MDR | Nov 2024 | Sep 02, 2027 | Amended |
| MDR QMS | US22/00000080 | Invacare Corporation | MDR | Sep 2022 | Sep 22, 2027 | |
| MDR QMS | FI22/00000011 | Icare Finland Oy | MDR | Aug 2024 | Oct 09, 2027 | Supplemented |
| MDR QMS | FI22/00000016 | Serres Oy | MDR | Mar 2024 | Nov 27, 2027 | Amended |
| MDR QMS | FI23/00000060 | Cerenion Ltd | MDR | Dec 2023 | Dec 27, 2027 | Issued |
| MDR QMS | FI23/1008001 | Shenzhen Yuezhongxing Technology Co., Ltd | MDR | Aug 2023 | Aug 23, 2028 | Issued |
| MDR QMS | FI23/00000033 | Sooma Oy | MDR | Aug 2023 | Aug 29, 2028 | Issued |
| MDR QMS | FI23/1008002 | Shenzhen Comen Medical Instruments Co.,LTD. | MDR | Jan 2024 | Sep 05, 2028 | Supplemented |
| MDR QMS | FI23/00000051 | NuvoAir AB | MDR | Oct 2023 | Oct 01, 2028 | Issued |
| MDR QMS | FI23/00000052 | PAUSCH Medical GmbH | MDR | Oct 2023 | Oct 24, 2028 | Issued |
| MDR QMS | FI23/1008004 | ChongQing Sunkingdom Medical Instrument Co. Ltd | MDR | Dec 2023 | Dec 27, 2028 | Issued |
| MDR QMS | FI24/0000001 | General Medical Italia LTD Swiss Branch | MDR | Jan 2024 | Jan 09, 2029 | Issued |
| MDR QMS | FI24/1008005 | Shenzhen Jumper Medical Equipment Co.,Ltd | MDR | Feb 2024 | Feb 21, 2029 | Issued |
| MDR QMS | FI24/1008007 | CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD | MDR | Apr 2024 | Apr 23, 2029 | Issued |
| MDR QMS | FI24/00000041 | Fimet Oy | MDR | Sep 2024 | May 23, 2029 | Supplemented |
| MDR QMS | FI24/00000061 | Optomed Oyj | MDR | Sep 2024 | Jun 05, 2029 | Issued |
| MDR QMS | FI24/00000064 | Fiagon GmbH | MDR | Oct 2024 | Oct 27, 2029 | Issued |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Vitec Codea Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Serres Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Optomed Oyj | 🇫🇮 Finland | 1 | 1 | 0 |
| Icare Finland Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Fimet Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Fiagon GmbH | 🇩🇪 Germany | 1 | 1 | 0 |
| Combinostics Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| ChongQing Sunkingdom Medical Instrument Co. Ltd | 🇨🇳 China | 1 | 1 | 0 |
| CHONGQING YEASN SCIENCE - TECHNOLOGY CO., LTD | 🇨🇳 China | 1 | 1 | 0 |
| Shenzhen Comen Medical Instruments Co.,LTD. | 🇨🇳 China | 1 | 1 | 0 |
| Shenzhen Jumper Medical Equipment Co.,Ltd | 🇨🇳 China | 1 | 1 | 0 |
| Planmed Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| NuvoAir AB | 🇸🇪 Sweden | 1 | 1 | 0 |
| General Medical Italia LTD Swiss Branch | 🇨🇭 Switzerland | 1 | 1 | 0 |
| Cerenion Ltd | 🇫🇮 Finland | 1 | 1 | 0 |
| Shenzhen Yuezhongxing Technology Co., Ltd | 🇨🇳 China | 1 | 1 | 0 |
| PAUSCH Medical GmbH | 🇩🇪 Germany | 1 | 1 | 0 |
| Rhyk Technologies GmbH | 🇩🇪 Germany | 1 | 1 | 1 |
| Sooma Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Shenzhen Dongdixin Technology Co., Ltd. | 🇨🇳 China | 1 | 0 | 0 |
| Disior Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Gründler GmbH | 🇩🇪 Germany | 1 | 0 | 0 |
| Invacare Corporation | 🇺🇸 United States | 1 | 1 | 0 |