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Mnchip
EUDAMEDClass IVD General (EU MDR)
Ref 213078Model Type B：1 Test / Disc, 10 Discs / Box
Identity
- Trade Name
- MNCHIP EUDAMED
- Device Name
- Liver Function Panel Lyophilized Kit EUDAMED
- Model / Reference
- Type B：1 Test / Disc, 10 Discs / Box EUDAMED213078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69703904811200 EUDAMED
- Basic UDI-DI
- B-69703904811200 EUDAMED
- EMDN Code
- W0101060499 MULTIPLE PARAMETERS POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Mnchip by Tianjin MNCHIP Technologies Co., Ltd — Class IVD General — 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-69703904811200 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tianjin MNCHIP Technologies Co., Ltd
- EUDAMED SRN
- CN-MF-000029863
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 7f27d0ee-b50c-4211-8501-7703030061de 61 fields · synced Jun 18, 2026