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MIA FORA NGS MFlex 6 HLA Typing Kit, 96 test
EUDAMEDClass C (EU MDR)
Ref SR-800-10535-96
Identity
- Trade Name
- MIA FORA NGS MFlex 6 HLA Typing Kit, 96 test EUDAMED
- Device Name
- MIA FORA NGS MFlex HLA Typing Kit & Software EUDAMED
- Model / Reference
- SR-800-10535-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234100843 EUDAMED
- Basic UDI-DI
- 88823412W01030403C00000YJ EUDAMED
- Direct Marketing DI
- 10888234100843 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 6 HLA Typing Kit, 96 test 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 09fb46bb-0e83-478a-afec-7f78681897e3 61 fields · synced Jul 11, 2026