Identity
- Trade Name
- OzTGSO HLA MX11 Typing Kit EUDAMED
- Device Name
- OzTGSO HLA MX11 Typing Kit EUDAMED
- Model / Reference
- 58010, 58011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04718050362028 EUDAMED
- Basic UDI-DI
- 47180503600580107Z EUDAMED
- Direct Marketing DI
- 04718050362028 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class C 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
New Device
Yes
EUDAMED
OzTGSO HLA MX11 Typing Kit by TBG Biotechnology Corp. — 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 | 47180503600580107Z | Class C | Active |
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Manufacturer
- Manufacturer
- TBG Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000029664
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 161f900a-0c03-4094-8c90-0aea12959e58 61 fields · synced Jul 12, 2026
- EUDAMED 161f900a-0c03-4094-8c90-0aea12959e58-1 61 fields · synced Jun 10, 2026