Notified Body
NB 0402
🇸🇪 Sweden
RISE Research Institutes of Sweden AB
Box 857, 50115 BORAS, Sweden
View on EUDAMED
Updated Oct 1, 2021
Certificates
4
Valid
0
Expiring < 6mo
0
Expired
4
Basic UDI-DIs
14
Devices
14
Manufacturers
3
Cert. Types
2
Basic Information
- Address
- Box 857, 50115 BORAS, Sweden
- [email protected]
- Phone
- 46 (0) 10 516 50 00
Regulatory Overview
Regulation
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Eu Mdd
14
Classification
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Eu Md Class 2a
13
Eu Md Class 1
1
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | C002239 | Interlinked AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | SC0538-18 | Aktiebolaget Ulax | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | SC0528-18 | Aktiebolaget Ulax | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | C000857LVFS | Pharmiva AB | May 26, 2024 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Aktiebolaget Ulax | 🇸🇪 Sweden | 2 | 0 | 0 |
| Interlinked AB | 🇸🇪 Sweden | 1 | 0 | 0 |
| Pharmiva AB | 🇸🇪 Sweden | 1 | 0 | 0 |