Identity
- Device Name
- HOMOCYSTEINE CONTROL I/II EUDAMED
- Model / Reference
- 18058 EUDAMED18059 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287101706 EUDAMED08435287101713 EUDAMED
- Basic UDI-DI
- B-08435287101706 EUDAMEDB-08435287101713 EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Homocysteine Control I/Ii 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-08435287101706 | 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 de856bbc-9249-482e-acc0-4fcca1e46039 61 fields · synced Sep 17, 2026
- EUDAMED 91c99a65-61ee-4335-8b93-79b88299c061 61 fields · synced May 18, 2026