Identity
- Trade Name
- HLAB27GUARD EUDAMED
- Device Name
- HLAB27GUARD EUDAMED
- Model / Reference
- AB0022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760322820119 EUDAMED
- Basic UDI-DI
- 376032282CGENHLAB27J6 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Hlab27guard by Appolon Bioteck — 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 | 376032282CGENHLAB27J6 | Class C | Active |
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Manufacturer
- Manufacturer
- Appolon Bioteck
- EUDAMED SRN
- FR-MF-000022234
Sources (1)
- EUDAMED 63129caf-3d6c-45b8-89a4-2337e11ceb71 61 fields · synced Jun 18, 2026