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Automated Small Specific Protein Analyzer
EUDAMEDClass A (EU MDR)
Ref HE10015Model MU500
Identity
- Device Name
- Automated Small Specific Protein Analyzer EUDAMED
- Model / Reference
- MU500 EUDAMEDHE10015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838802529 EUDAMED
- Basic UDI-DI
- 697583880MS003QU EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automated Small Specific Protein Analyzer by Zhejiang Pushkang Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697583880MS003QU | Class A | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED d71329f6-036e-4e9a-adcc-a3ef950041e8 61 fields · synced Jun 19, 2026