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Total Bilirubin (T.BIL) Assay Kit (SCR Oxidation Method)
EUDAMEDClass IVD General (EU MDR)
Ref 54H50TRef 54H225TSCRef 54H225TRef 54H50TSC
Identity
- Trade Name
- Total Bilirubin (T.BIL) Assay Kit (SCR Oxidation Method) EUDAMED
- Device Name
- Total Bilirubin (T.BIL) Assay Kit (SCR Oxidation Method) EUDAMED
- Model / Reference
- 54H50T EUDAMED54H225TSC EUDAMED54H225T EUDAMED54H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-54H50TW4 EUDAMEDD-54H225TSC9E EUDAMEDD-54H225T9A EUDAMEDD-54H50TSCTC EUDAMED
- Basic UDI-DI
- B-54H50TW4 EUDAMEDB-54H225TSC9E EUDAMEDB-54H225T9A EUDAMEDB-54H50TSCTC 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
No
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 (T.BIL) Assay Kit (SCR Oxidation Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-54H50TW4 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (4)
- EUDAMED c42b87de-a5ec-414a-8deb-f69479de32fa 61 fields · synced Oct 6, 2026
- EUDAMED be866159-8908-4c09-a719-6a27ae63f36a 61 fields · synced May 17, 2026
- EUDAMED 7786b196-17bd-48e9-88e3-04cf9ce4234f 61 fields · synced May 18, 2026
- EUDAMED c8945426-48f4-4b94-9dc8-32054347db4a 61 fields · synced May 19, 2026