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Haptoglobin (HAPT) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 145H40TSCRef 145H240TSC
Identity
- Trade Name
- Haptoglobin (HAPT) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Haptoglobin (HAPT) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 145H40TSC EUDAMED145H240TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-145H40TSC54 EUDAMEDD-145H240TSCMK EUDAMED
- Basic UDI-DI
- B-145H40TSC54 EUDAMEDB-145H240TSCMK EUDAMED
- EMDN Code
- W0102010302 HAPTOGLOBIN 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
Haptoglobin (HAPT) Assay Kit (Immunoturbidimetric 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-145H40TSC54 | 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 26354596-a2a3-464b-a6f2-88c0601f23cb 61 fields · synced Jul 15, 2026
- EUDAMED e57b4254-df02-4a8e-8424-8c8ab3dc7c6c 61 fields · synced May 18, 2026