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Microalbumin (MALB) Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 80H50TSC
Identity
- Trade Name
- Microalbumin (MALB) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Microalbumin (MALB) Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 80H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-80H50TSCSZ EUDAMED
- Basic UDI-DI
- B-80H50TSCSZ EUDAMED
- EMDN Code
- W0102010309 ALBUMIN (IC) INCL. UALBUMIN 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
Microalbumin (MALB) 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-80H50TSCSZ | 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 (1)
- EUDAMED 5fa878ab-ff1f-4cde-8bfb-6398e98baea1 61 fields · synced Jun 18, 2026