Identity
- Trade Name
- Anti-H Mono-Type EUDAMED
- Device Name
- Anti-H Mono-Type EUDAMED
- Model / Reference
- 215520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436583731673 EUDAMED
- Basic UDI-DI
- 843658373ANTISERA017H4 EUDAMED
- EMDN Code
- W0103030501 OTHER ANTIGEN TYPING REAGENTS 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
Anti-H Mono-Type by Diagnostic Grifols, 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 | 843658373ANTISERA017H4 | Class C | Active |
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Manufacturer
- Manufacturer
- Diagnostic Grifols, S.A.
- EUDAMED SRN
- ES-MF-000000784
Sources (1)
- EUDAMED 106d399a-bcc0-43e5-89d8-d90f91bf4801 61 fields · synced Jun 19, 2026