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MIA FORA NGS MFlex 11 HT HLA Typing Kit
EUDAMEDClass C (EU MDR)
Ref SR-800-10534-1152
Identity
- Trade Name
- MIA FORA NGS MFlex 11 HT HLA Typing Kit EUDAMED
- Device Name
- MIA FORA NGS MFlex HLA Typing Kit & Software EUDAMED
- Model / Reference
- SR-800-10534-1152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234100850 EUDAMED
- Basic UDI-DI
- 88823412W01030403C00000YJ EUDAMED
- Direct Marketing DI
- 10888234100850 EUDAMED
- EMDN Code
- W01030403,W01030499 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
New Device
No
EUDAMED
MIA FORA NGS MFlex 11 HT HLA Typing Kit by Bioarray Solutions Ltd — 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 | 88823412W01030403C00000YJ | Class C | Active |
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Manufacturer
- Manufacturer
- BioArray Solutions Ltd
- EUDAMED SRN
- US-MF-000022068
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (1)
- EUDAMED 9750ce14-1973-4ec7-ae26-0150ad1c55e7 61 fields · synced Jul 22, 2026