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HLAssure SE C Locus SBT Kit
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 50410
Identity
- Trade Name
- HLAssure SE C Locus SBT Kit EUDAMED
- Device Name
- HLAssure SE C Locus SBT Kit EUDAMED
- Model / Reference
- 50410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04718050361366 EUDAMED
- Basic UDI-DI
- B-04718050361366 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy 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
HLAssure SE C Locus SBT Kit by TBG Biotechnology Corp. — Class IVD Annex II List B — 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-04718050361366 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- TBG Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000029664
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED c25e9db7-6750-475e-8f88-51b3e2d449f8 61 fields · synced Jun 19, 2026