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Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)
EUDAMEDClass IVD General (EU MDR)
Ref 51H60TRef 51H60TSC
Identity
- Trade Name
- Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method) EUDAMED
- Device Name
- Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method) EUDAMED
- Model / Reference
- 51H60T EUDAMED51H60TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-51H60TV8 EUDAMEDD-51H60TSCS4 EUDAMED
- Basic UDI-DI
- B-51H60TV8 EUDAMEDB-51H60TSCS4 EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - TOTAL 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
Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring 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-51H60TV8 | 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 d43a84a6-e9be-4535-ae70-01f3dfc977e7 61 fields · synced Oct 6, 2026
- EUDAMED 71aff20e-ee8a-4484-83a8-3eace0b0f695 61 fields · synced May 18, 2026