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Direct Bilirubin Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref DB6011Y, DB6012Y, DB6013Y, DB6014Y, DB6015Y, DB6011N, DB6012N, DB6013N, DB6014N, DB6015N
Identity
- Trade Name
- Direct Bilirubin Reagent Kit EUDAMED
- Device Name
- Direct Bilirubin Reagent Kit EUDAMED
- Model / Reference
- DB6011Y, DB6012Y, DB6013Y, DB6014Y, DB6015Y, DB6011N, DB6012N, DB6013N, DB6014N, DB6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-DB601QN EUDAMED
- Basic UDI-DI
- B-DB601QN 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
Direct 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-DB601QN | 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 51c2f0ee-8d27-4108-b170-f897fc3b21fb 61 fields · synced Jun 18, 2026
- EUDAMED 51c2f0ee-8d27-4108-b170-f897fc3b21fb-1 61 fields · synced Jun 9, 2026