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Urinary Total Protein (UTP) Assay Kit (Pyrogallol Red Molybdenum Method)
EUDAMEDClass IVD General (EU MDR)
Ref R: 2×60 mL
Identity
- Device Name
- Urinary Total Protein (UTP) Assay Kit (Pyrogallol Red Molybdenum Method) EUDAMED
- Model / Reference
- R: 2×60 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300230 EUDAMED
- Basic UDI-DI
- B-06937287300230 EUDAMED
- EMDN Code
- W01010230 TOTAL PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Urinary Total Protein (UTP) Assay Kit (Pyrogallol Red Molybdenum Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in…
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-06937287300230 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 52ada6cf-07e5-46e7-84f4-b078befc6804 61 fields · synced Jun 19, 2026