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Coagulation Control I/Ii
EUDAMEDClass IVD General (EU MDR)
Ref 61013Ref 61008Ref 61007Ref 61012
Identity
- Device Name
- COAGULATION CONTROL I/II EUDAMED
- Model / Reference
- 61013 EUDAMED61008 EUDAMED61007 EUDAMED61012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287112184 EUDAMED08435287100389 EUDAMED08435287100372 EUDAMED08435287112177 EUDAMED
- Basic UDI-DI
- B-08435287112184 EUDAMEDB-08435287100389 EUDAMEDB-08435287100372 EUDAMEDB-08435287112177 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 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-08435287112184 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (4)
- EUDAMED 0ded3baf-1914-48e9-a131-dac3f982c2be 61 fields · synced Jul 28, 2026
- EUDAMED 3c6240fc-00df-43a0-b376-2a965eb46fd3 61 fields · synced May 16, 2026
- EUDAMED 37f29090-f323-459e-ab86-64cf1963a06c 61 fields · synced May 18, 2026
- EUDAMED 2d165350-00af-41d1-a36f-ea02b175b741 61 fields · synced May 19, 2026