Notified Body
NB 0543
🇩🇰 Denmark
Presafe Denmark A/S
Tuborg Parkvej 8, DK-2900 Hellerup, Denmark
View on EUDAMED
Updated Oct 1, 2021
Certificates
9
Valid
0
Expiring < 6mo
0
Expired
9
Basic UDI-DIs
134
Devices
134
Manufacturers
2
Cert. Types
4
Basic Information
- Address
- Tuborg Parkvej 8, DK-2900 Hellerup, Denmark
- [email protected]
- Phone
- 45/39.45.49.99
Regulatory Overview
Regulation
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Eu Ivdd
134
Classification
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Eu Ivd Annex 2 List A
134
Device Types
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Certificate Health
Total
9
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
9
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex VII Section 5 | DGM-492 | Eldon Biologicals A/S | Dec 18, 2023 | |||
| IVDD Annex VII Section 5 | 0543 | Eldon Biologicals A/S | Dec 18, 2023 | |||
| IVDD Annex V | DGM-491 | Eldon Biologicals A/S | May 26, 2024 | |||
| IVDD Annex V | DGM - 491 | Eldon Biologicals A/S | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | DGM-549 | bioLytical Laboratories Inc. | May 26, 2024 | |||
| IVDD Annex IV Section 4 | DGM-548 | bioLytical Laboratories Inc. | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | DGM-0549 | bioLytical Laboratories Inc. | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | DGM-459 | bioLytical Laboratories Inc. | May 26, 2024 | |||
| IVDD Annex IV Section 4 | DGM-458 | bioLytical Laboratories Inc. | May 26, 2024 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| bioLytical Laboratories Inc. | 🇨🇦 Canada | 5 | 0 | 0 |
| Eldon Biologicals A/S | 🇩🇰 Denmark | 4 | 0 | 0 |