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Total Bilirubin Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref TB6011Y, TB6012Y, TB6013Y, TB6014Y, TB6015Y, TB6011N, TB6012N, TB6013N, TB6014N, TB6015N TB6021Y, TB6022Y
Identity
- Trade Name
- Total Bilirubin Reagent Kit EUDAMED
- Device Name
- Total Bilirubin Reagent Kit EUDAMED
- Model / Reference
- TB6011Y, TB6012Y, TB6013Y, TB6014Y, TB6015Y, TB6011N, TB6012N, TB6013N, TB6014N, TB6015N TB6021Y, TB6022Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-TB601W6 EUDAMED
- Basic UDI-DI
- B-TB601W6 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-TB601W6 | 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 ab3e7c55-1fd8-4357-bb30-abb79370800c 61 fields · synced Jul 10, 2026
- EUDAMED ab3e7c55-1fd8-4357-bb30-abb79370800c-1 61 fields · synced Jun 10, 2026