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Mnchip
EUDAMEDClass IVD General (EU MDR)
Ref 213082Model Type B：1 Test / Disc, 10 Discs / BoxRef 213079Ref 213080Ref 213077Ref 213048
Identity
- Trade Name
- MNCHIP EUDAMED
- Device Name
- Glucose and Lipid Panel Lyophilized Kit EUDAMEDRenal Function Panel Lyophilized Kit EUDAMEDLiver and Renal Function Lyophilized Kit EUDAMEDGeneral Chemistry IV Lyophilized Kit EUDAMEDGeneral Chemistry II Lyophilized Kit EUDAMED
- Model / Reference
- Type B：1 Test / Disc, 10 Discs / Box EUDAMED213082 EUDAMED213079 EUDAMED213080 EUDAMED213077 EUDAMED213048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69703904811064 EUDAMED69703904811132 EUDAMED69703904811378 EUDAMED69703904810388 EUDAMED69703904810760 EUDAMED
- Basic UDI-DI
- B-69703904811064 EUDAMEDB-69703904811132 EUDAMEDB-69703904811378 EUDAMEDB-69703904810388 EUDAMEDB-69703904810760 EUDAMED
- EMDN Code
- W0101060499 MULTIPLE PARAMETERS POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMEDSpain 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-69703904811064 | 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 (5)
- EUDAMED 60eab520-10ee-439a-9620-53830789eefe 61 fields · synced Jul 23, 2026
- EUDAMED 52d68326-37f8-437b-a4d4-5c89fc5eac86 61 fields · synced May 17, 2026
- EUDAMED 03186be4-c7b4-4ee9-adfd-b7c7187bcc17 61 fields · synced May 18, 2026
- EUDAMED 5f4db92a-b5bf-49e8-91b5-19eb5135446d 61 fields · synced May 18, 2026
- EUDAMED c173113a-1788-4a51-bc11-0cb12b283c9c 61 fields · synced May 18, 2026