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Vitamin B12 Fast Test Kit (Immunofluorescence Assay)
EUDAMEDClass B (EU MDR)
Ref IF5070
Identity
- Trade Name
- Vitamin B12 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Device Name
- Vitamin B12 Fast Test Kit (Immunofluorescence Assay) EUDAMED
- Model / Reference
- IF5070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414724325 EUDAMED
- Basic UDI-DI
- 695441470258HM EUDAMED
- EMDN Code
- W0102070204 VITAMIN B12 EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Vitamin B12 Fast Test Kit (Immunofluorescence Assay) by Getein Biotech, Inc. — Class B — 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 | 695441470258HM | Class B | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 17e30d29-9244-4c64-adac-2250830bbf44 61 fields · synced Jun 18, 2026