Identity
- Trade Name
- Asserachrom® HPIA - IgG EUDAMED
- Device Name
- Asserachrom® HPIA - IgG EUDAMED
- Model / Reference
- 00624 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03607450006247 EUDAMED
- Basic UDI-DI
- B-03607450006247 EUDAMED
- EMDN Code
- W0103020615 COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Asserachrom® HPIA - IgG by Diagnostica Stago — 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-03607450006247 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (1)
- EUDAMED e67b2315-8c1e-494b-b86f-feeac28e0bae 61 fields · synced Jul 25, 2026