Identity
- Trade Name
- MNCHIP EUDAMED
- Device Name
- Chemistry Analyzer EUDAMED
- Model / Reference
- Pointcare M4 EUDAMED110033 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69703904810142 EUDAMED
- Basic UDI-DI
- 69703904810148E EUDAMED
- Direct Marketing DI
- 69703904810142 EUDAMED
- EMDN Code
- W02010199 CHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Mnchip by Tianjin MNCHIP Technologies Co., Ltd — Class A — 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 | 69703904810148E | Class A | 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 4cab6ee1-0877-4fcc-9f14-df3c6544589a 61 fields · synced Jun 18, 2026