Identity
- Device Name
- nDNA POSITIVE CONTROL EUDAMED
- Model / Reference
- 44894 EUDAMED44542 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287106190 EUDAMED08435287145427 EUDAMED
- Basic UDI-DI
- B-08435287106190 EUDAMEDB-08435287145427 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
nDNA POSITIVE CONTROL by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08435287106190 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 3619cb61-eac5-40c4-959a-5cdc045fa430 61 fields · synced Jul 9, 2026
- EUDAMED 97ae6ade-c4ef-45fc-99a5-dd3ff10b3b74 61 fields · synced May 17, 2026