Identity
- Trade Name
- Coagulation calibrator EUDAMED
- Device Name
- Coagulation calibrator, 4 x 1 mL EUDAMED
- Model / Reference
- 104-0021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360388678675LK EUDAMED
- Basic UDI-DI
- B-084360388678675LK EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Coagulation calibrator by Chronolab Systems, S.L. — 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-084360388678675LK | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED e31cc82a-f44f-4e68-b523-4877d8791f68 61 fields · synced Jul 20, 2026