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Direct Bilirubin (D.BIL) Assay Kit (SCR Oxidation Method)
EUDAMEDClass IVD General (EU MDR)
Ref 55H50TSCRef 55H225T
Identity
- Trade Name
- Direct Bilirubin (D.BIL) Assay Kit (SCR Oxidation Method) EUDAMED
- Device Name
- Direct Bilirubin (D.BIL) Assay Kit (SCR Oxidation Method) EUDAMED
- Model / Reference
- 55H50TSC EUDAMED55H225T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-55H50TSCTV EUDAMEDD-55H225T9P EUDAMED
- Basic UDI-DI
- B-55H50TSCTV EUDAMEDB-55H225T9P 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
Direct Bilirubin (D.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-55H50TSCTV | 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 (2)
- EUDAMED 86792b39-368d-4de1-b611-58e04290a3b5 61 fields · synced Aug 1, 2026
- EUDAMED 5fb4a32a-28b2-458b-a3e5-29d4e43566b3 61 fields · synced May 19, 2026