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Total Bilirubin Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref TB-V6011Y, TB-V6012Y, TB-V6013Y, TB-V6014Y, TB-V6015Y, TB-V6011N, TB-V6012N, TB-V6013N, TB-V6014N, TB-V6015N
Identity
- Trade Name
- Total Bilirubin Reagent Kit EUDAMED
- Device Name
- Total Bilirubin Reagent Kit EUDAMED
- Model / Reference
- TB-V6011Y, TB-V6012Y, TB-V6013Y, TB-V6014Y, TB-V6015Y, TB-V6011N, TB-V6012N, TB-V6013N, TB-V6014N, TB-V6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TB-V601T9 EUDAMED
- Basic UDI-DI
- B-TB-V601T9 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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 Bilirubin 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-TB-V601T9 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED dfe31d7a-87a7-40e6-b8e5-0370b9f9392a 61 fields · synced Jul 18, 2026
- EUDAMED dfe31d7a-87a7-40e6-b8e5-0370b9f9392a-1 61 fields · synced Jun 10, 2026