← Back to catalogue
Total Protein Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref TP6011Y, TP6012Y, TP6013Y, TP6014Y, TP6015Y, TP6011N, TP6012N, TP6013N, TP6014N, TP6015N
Identity
- Trade Name
- Total Protein Reagent Kit EUDAMED
- Device Name
- Total Protein Reagent Kit EUDAMED
- Model / Reference
- TP6011Y, TP6012Y, TP6013Y, TP6014Y, TP6015Y, TP6011N, TP6012N, TP6013N, TP6014N, TP6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TP601Z8 EUDAMED
- Basic UDI-DI
- B-TP601Z8 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN 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
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
Total Protein Reagent Kit by Hangzhou Aichek Medical Technology 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-TP601Z8 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 963f1e03-65f0-4249-aa58-94092ce2449e 61 fields · synced Jun 19, 2026
- EUDAMED 963f1e03-65f0-4249-aa58-94092ce2449e-1 61 fields · synced Jun 10, 2026