Notified Body
NB 0537
🇫🇮 Finland
Eurofins Electric & Electronics Finland Oy
PL 47 Kivimiehentie 4, FI-02150 Espoo., Finland
View on EUDAMED
Updated Apr 20, 2022
Certificates
78
Valid
14
Expiring < 6mo
0
Expired
62
Basic UDI-DIs
851
Devices
851
Manufacturers
59
Cert. Types
9
Basic Information
- Address
- PL 47 Kivimiehentie 4, FI-02150 Espoo., Finland
- [email protected]
- Phone
- +358406311311
Regulatory Overview
Regulation
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Eu Mdd
759
Eu Ivdd
92
Classification
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Eu Md Class 2a
581
Eu Md Class 2b
129
Eu Ivd Annex 2 List B
89
Eu Md Class 1
48
Eu Ivd Self Testing
3
Eu Md Class 3
1
Device Types
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Certificate Health
Total
78
Valid
14
Expiring < 6mo
0
Expired / Withdrawn
62
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | C-01-1196-749-20 | PulseLavage AB | May 05, 2022 | |||
| MDD Annex II (excluding section 4) | VTT-C-12222-01-1200-628-17 | Oy Diagnostic Devices Development | Dec 14, 2022 | |||
| MDD Annex III | VTT-C-12222-1200-628-17 | Oy Diagnostic Devices Development | Dec 14, 2022 | |||
| MDD Annex II Section 4 | C-01-1201-737-20 | KiiltoClean Oy | Jan 08, 2023 | |||
| MDD Annex II Section 4 | C-01-1162-775-21 | Galena Pharma Oy | Mar 06, 2023 | |||
| MDD Annex II (excluding section 4) | C01-1162-775-21 | Galena Pharma Oy | Mar 07, 2023 | |||
| MDD Annex IV | VTT-C-12323-01-1027-6536-18 | Mediq Suomi Oy | Apr 22, 2023 | |||
| MDD Annex II (excluding section 4) | C-12524-01-1165-660-18 | Bone Index Finland Ltd | Jul 31, 2023 | |||
| MDD Annex II (excluding section 4) | C-01-1129-665-19 | LymphaTouch Inc. | Feb 15, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1202-767-21 | Precordior Ltd | Feb 19, 2024 | |||
| MDD Annex V | C-01-1127-672-19 | Berner Oy | Mar 17, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1130-684-19 | Vitabalans Oy | Mar 29, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1080-682-19 | LM-Instruments Oy | May 08, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1080-682-19 | LM-Instruments Oy | May 09, 2024 | |||
| MDD Annex V | C-01-1170-751-20 | BIOSE INDUSTRIE | May 21, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1190-724-20 | Oy Finnsusp Ab | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1+35-745-20 | DEKO MedTech Oy | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1190-724-20 | Oy Finnsusp Ab | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1186-771-21 | Aromtech Oy | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1035-745-20 | Franke Medical Oy | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1004-698-19 | GE Healthcare Finland Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1154-715-19 | PaloDEx Group Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1013-689-19 | Megin Oy | May 26, 2024 | |||
| MDD Annex II Section 4 | C-01-1183-760-21 | Pharmia Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1106-714-19 | PaloDEx Group Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1035-745-20 | DEKO MedTech Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1105-713-19 | PaloDEx Group Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1173-707-19 | AirLife Finland Oy | May 26, 2024 | |||
| MDD Annex VI | C-01-1102-741-20 | Mediracer Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1194-744-20 | Mectalent Oy | May 26, 2024 | |||
| MDD Annex V | C-01-1019-738-20 | Oy Fluorplast Ab | May 26, 2024 | |||
| MDD Annex V | C-01-1019-738-20 | Oy Fluorplast Ab | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1181-726-20 | Ocuspecto Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1124-728-20 | Repolar Pharmaceuticals Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1103-747-20 | Frescon Oy | May 26, 2024 | |||
| MDD Annex V | C-01-1140-725-20 | Biohit Oyj | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1204-706-19 | Heart2Save Oy | May 26, 2024 | |||
| MDD Annex II Section 4 | C-01-1030-730-20 | Bittium Biosignals Ltd | May 26, 2024 | |||
| MDD Annex II Section 4 | C-01-1056-690-20 | Medikro Ltd | May 26, 2024 | |||
| MDD Annex VI | C-01-1002-764-21 | Finndent Oy | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-O1-1175-721-20 | Modulight Corporation | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1158-756-21 | Meridian Medical Oy | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1189-729-20 | Eko Health, Inc. | May 27, 2024 | |||
| MDD Annex V | C-01-1068-753-20 | Delfin Technologies Ltd | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1154-715-19 | PaloDEx Group Oy | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1173-707-19 | AirLife Finland Oy | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1173-707-19 | AirLife Finland Oy | May 27, 2024 | |||
| MDD Annex II Section 4 | C-01-1056-690-19 | Medikro Ltd | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1210-718-19 | Reapplix A/S | May 27, 2024 | |||
| MDD Annex V | C-01-1019-738-20 | Oy Fluorplast Ab | May 27, 2024 | |||
| MDD Annex V | C-01-1019-738-20 | Oy Fluorplast Ab | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1205-754-20 | Suunto Oy | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1203-732-20 | Surgify Medical Oy | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | C-01-1156-735-20 | CGI Suomi Oy | May 28, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | C-02-1088-787-22 | Wallac Oy | Oct 29, 2024 | |||
| MDD Annex II (excluding section 4) | EUFI29-21000160-S | Nexstim Plc | Jan 10, 2025 | |||
| IVDD Annex III Section 6 | C-02-1172-802-22 | Labsystems Diagnostics Oy | May 25, 2025 | |||
| IVDD Annex III Section 6 | C-02-1172-804-22 | Labsystems Diagnostics Oy | May 25, 2025 | |||
| IVDD Annex III Section 6 | C-02-1206-801-22 | Calpro AS | May 25, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | C-02-1073-797-22 | Tyson Bioresearch, Inc. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | C-02-1172-794-22 | Labsystems Diagnostics Oy | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | C-02-1073-797-22 | Tyson Bioresearch, Inc. | May 26, 2025 | |||
| MDR QMS | CR-03-1004-836-24 | GE Healthcare Finland Oy | MDR | Jul 2024 | Feb 08, 2027 | Supplemented |
| MDR QMS | CR-03-1224-781-22 | PulseOn Oy | MDR | Feb 2022 | Feb 25, 2027 | Issued |
| MDR QMS | CR-03-1201-785-22 | KiiltoClean Oy | MDR | May 2022 | May 11, 2027 | Issued |
| MDR QMS | CR-03-1154-812-23 | PaloDEx Group Oy | MDR | May 2024 | Mar 06, 2028 | Supplemented |
| MDR QMS | CR-03-1229-813-23 | Movesense Ltd | MDR | Oct 2024 | Apr 06, 2028 | Supplemented |
| MDR QMS | CR-03-1087-817-23 | Nexstim Plc | MDR | May 2023 | May 16, 2028 | Issued |
| MDR QMS | CR-03-1035-840-24 (01) | DEKO MedTech Oy | MDR | Apr 2024 | May 30, 2028 | Supplemented |
| MDR QMS | CR-03-1226-821-23 | Tietoevry Finland Oy | MDR | Nov 2024 | Aug 11, 2028 | Supplemented |
| MDR QMS | CR-03-1231-829-23 | Tietoevry Sweden AB | MDR | Apr 2024 | Oct 27, 2028 | Supplemented |
| MDR QMS | CR-03-1230-861-24 | Orion Corporation | MDR | Dec 2024 | Dec 22, 2028 | Supplemented |
| MDD Annex II Section 4 | THTR-02-L14 | Willingsford NL | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | C-01-1220-769-21 | The wellbeing services county of Southwest Finland | Dec 31, 2028 | |||
| MDR QMS | CR-03-1228-849-24 | Tietoevry AB | MDR | Nov 2024 | Jun 26, 2029 | Supplemented |
| MDR QMS | CR-03-1220-858-24 | The wellbeing services county of Southwest Finland | MDR | Nov 2024 | Nov 25, 2029 | Issued |
| MDR QMS | CR-03-1156-859-24 | CGI Suomi Oy | MDR | Dec 2024 | Dec 09, 2029 | Issued |
| MDR QMS | CR-03-1233-860-24 | Neuro Event Labs Oy | MDR | Dec 2024 | Dec 20, 2029 | Issued |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Oy Fluorplast Ab | 🇫🇮 Finland | 4 | 0 | 0 |
| PaloDEx Group Oy | 🇫🇮 Finland | 4 | 0 | 0 |
| AirLife Finland Oy | 🇫🇮 Finland | 3 | 0 | 0 |
| Labsystems Diagnostics Oy | 🇫🇮 Finland | 3 | 0 | 0 |
| Oy Finnsusp Ab | 🇫🇮 Finland | 2 | 0 | 0 |
| Medikro Ltd | 🇫🇮 Finland | 2 | 0 | 0 |
| CGI Suomi Oy | 🇫🇮 Finland | 2 | 1 | 0 |
| Galena Pharma Oy | 🇫🇮 Finland | 2 | 0 | 0 |
| The wellbeing services county of Southwest Finland | 🇫🇮 Finland | 2 | 1 | 0 |
| LM-Instruments Oy | 🇫🇮 Finland | 2 | 0 | 0 |
| DEKO MedTech Oy | 🇫🇮 Finland | 2 | 0 | 0 |
| Tyson Bioresearch, Inc. | 🇹🇼 Taiwan | 2 | 0 | 0 |
| Oy Diagnostic Devices Development | 🇫🇮 Finland | 2 | 0 | 0 |
| Aromtech Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Surgify Medical Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Mectalent Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Suunto Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Calpro AS | 🇳🇴 Norway | 1 | 0 | 0 |
| Vitabalans Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Movesense Ltd | 🇫🇮 Finland | 1 | 1 | 0 |
| KiiltoClean Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| PulseLavage AB | 🇸🇪 Sweden | 1 | 0 | 0 |
| BIOSE INDUSTRIE | 🇫🇷 France | 1 | 0 | 0 |
| Ocuspecto Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Repolar Pharmaceuticals Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Nexstim Plc | 🇫🇮 Finland | 1 | 0 | 0 |
| Frescon Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Biohit Oyj | 🇫🇮 Finland | 1 | 0 | 0 |
| Franke Medical Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Heart2Save Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Bittium Biosignals Ltd | 🇫🇮 Finland | 1 | 0 | 0 |
| Bone Index Finland Ltd | 🇫🇮 Finland | 1 | 0 | 0 |
| Finndent Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Modulight Corporation | 🇫🇮 Finland | 1 | 0 | 0 |
| Precordior Ltd | 🇫🇮 Finland | 1 | 0 | 0 |
| Neuro Event Labs Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Orion Corporation | 🇫🇮 Finland | 1 | 1 | 0 |
| Tietoevry AB | 🇸🇪 Sweden | 1 | 1 | 0 |
| Tietoevry Finland Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| GE Healthcare Finland Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| PaloDEx Group Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Tietoevry Sweden AB | 🇸🇪 Sweden | 1 | 1 | 0 |
| DEKO MedTech Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Nexstim Plc | 🇫🇮 Finland | 1 | 1 | 0 |
| KiiltoClean Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| PulseOn Oy | 🇫🇮 Finland | 1 | 1 | 0 |
| Wallac Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| GE Healthcare Finland Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Megin Oy | 🇫🇮 Finland | 1 | 0 | 0 |
| Meridian Medical Oy | 🇫🇮 Finland | 1 | 0 | 0 |