Notified Body
NB 598
🇫🇮 Finland
SGS FIMKO OY
Takomotie 8, 00380 HELSINKI, Finland
View on EUDAMED
Updated Oct 1, 2021
Certificates
52
Valid
0
Expiring < 6mo
0
Expired
47
Basic UDI-DIs
178
Devices
178
Manufacturers
37
Cert. Types
3
Basic Information
- Address
- Takomotie 8, 00380 HELSINKI, Finland
- [email protected]
- Phone
- 358 9 696 361
Regulatory Overview
Regulation
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Eu Mdd
178
Classification
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Eu Md Class 2a
115
Eu Md Class 1
34
Eu Md Class 2b
29
Device Types
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Certificate Health
Total
52
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
47
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | FI21/07045P0 | Forsante Oy | Sep 25, 2023 | |||
| MDD Annex II (excluding section 4) | FI15/07006 | Planmeca Oy | Nov 12, 2023 | |||
| MDD Annex II (excluding section 4) | FI15/07006 | Planmeca Oy | Nov 13, 2023 | |||
| MDD Annex II (excluding section 4) | FI14/07007 | Innokas Yhtymä Oy | Jan 26, 2024 | |||
| MDD Annex II (excluding section 4) | FI1907010 | Takagi seiko | Mar 31, 2024 | |||
| MDD Annex V | FI19/07011 | Takagi seiko | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | Fl19/07010 | Takagi seiko | Mar 31, 2024 | |||
| MDD Annex II (excluding section 4) | FI16/07012 | Combinostics Oy | May 22, 2024 | |||
| MDD Annex II (excluding section 4) | FI17/07013 | Icare Finland Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI19/07005 | Fimet Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/871811 | Cerenion Ltd | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI14/07012 | Sooma Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI17-07012 | Icare Finland Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI15/07001 | Mediconsult Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/871789 | Fysioline Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI21/07001 | Shenzhen Comen Medical Instruments Co.,LTD. | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | F120/42158 | Acoresmed Co., Ltd. | May 23, 2024 | |||
| MDD Annex V | FI14/07008 | David Health Solutions Oy | May 23, 2024 | |||
| MDD Annex V | FI14/07008 | David Health Solutions Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI21/871843 | Koite Health Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | Fi15/07001 | Mediconsult Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/971789 | Fysioline Oy | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | FI13/07001 | Optomed Oyj | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI21/871845 | Evondos Oy | May 24, 2024 | |||
| MDD Annex V | FI17/07/007 | Monidor Oy | May 24, 2024 | |||
| MDD Annex V | FI19/819943382 | TOWA MEDICAL INSTRUMENTS CO.,LTD. | May 24, 2024 | |||
| MDD Annex V | FI21/07003 | Foshan Hongfeng Co. Ltd. | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | F120/07003 | AViTA Corporation | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 120/07003 F | AViTA Corporation | May 24, 2024 | |||
| MDD Annex II Section 4 | FI17/07012 | Icare Finland Oy | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI15/07007 | Planmed Oy | May 24, 2024 | |||
| MDD Annex II Section 4 | FI2000010 | Leltek Inc. | May 24, 2024 | |||
| MDD Annex V | FI21/07010 | Guangzhou AXD Electronic Co., Ltd. | May 24, 2024 | |||
| MDD Annex V | 07003 | Foshan Hongfeng Co. Ltd. | May 24, 2024 | |||
| MDD Annex V | FI21/07006 | Shenzhen Nile Biotechnology Co., Ltd. | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI120/07001P0 | Optomed Oyj | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI13/07001 | Optomed Oyj | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/871798 | VitalSignum Oy | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | Fl21/07001 | Shenzhen Comen Medical Instruments Co.,LTD. | May 24, 2024 | |||
| MDD Annex V | FI20/07020 | Guangzhou Longest Science & Technology Co., Ltd. | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI18/7006 | TherMidas Oy | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/871787 | Disior Oy | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI21/871841 | ProWellness Health Solutions Oy | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/07011 | QT Medical, Inc. | May 24, 2024 | |||
| MDD Annex V | FI20/871795 | Pedihealth Oy | May 24, 2024 | |||
| MDD Annex V | FI15/07010 | FOSHAN CHUANGXIN MEDICAL APPARATUS CO.,LTD | Dec 03, 2024 | |||
| MDD Annex V | FI15/07009 | FOSHAN CHUANGXIN MEDICAL APPARATUS CO.,LTD | Dec 03, 2024 | |||
| MDD Annex II (excluding section 4) | FI20/07003 | AViTA Corporation | Dec 30, 2028 | |||
| MDD Annex II (excluding section 4) | FI17/07005 | Hetaida Technology Co., Ltd. | Dec 31, 2028 | |||
| MDD Annex V | FI20/07012 | GuangDong EDA Technology Co., Ltd. | Dec 31, 2028 | |||
| MDD Annex V | FI17/07009 | Shenzhen Fitconn Technology Co.,ltd | Dec 31, 2028 | |||
| MDD Annex V | 17/07002 | Aerotel Medical Systems (1998) Ltd. | Dec 31, 2028 |