Identity
- Trade Name
- D-Dimer Calibrator EUDAMED
- Device Name
- D-Dimer EUDAMED
- Model / Reference
- 01R1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436003070733 EUDAMED
- Basic UDI-DI
- 8436003070726XV EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
D-Dimer Calibrator by Biokit, S.a. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8436003070726XV | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 0c0e51ab-5d57-400b-ba6a-645f341cfbc6 61 fields · synced Jul 10, 2026