Identity
- Device Name
- COAGULATION CALIBRATOR EUDAMED
- Model / Reference
- 61015 EUDAMED61006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287112191 EUDAMED08435287100365 EUDAMED
- Basic UDI-DI
- B-08435287112191 EUDAMEDB-08435287100365 EUDAMED
- EMDN Code
- W0103010599 HAEMATOLOGY CONTROLS - 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
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
Coagulation Calibrator 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-08435287112191 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 37ef55f2-a45b-46b0-981c-0942a87d626e 61 fields · synced Jul 20, 2026
- EUDAMED 2306d417-b9ca-4e5d-91c0-b67806ed1cdd 61 fields · synced May 18, 2026