Identity
- Trade Name
- SAA Assay Kit EUDAMED
- Device Name
- SAA Assay Kit EUDAMED
- Model / Reference
- HE50103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975838800938 EUDAMED
- Basic UDI-DI
- B-06975838800938 EUDAMED
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia 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
SAA Assay Kit by Zhejiang Pushkang Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975838800938 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Pushkang Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042656
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 7de242f5-e9b6-40d5-be29-4ae829409703 61 fields · synced Jul 9, 2026