Identity
- Model / Reference
- AA05-01-24S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977805760214 EUDAMED
- Basic UDI-DI
- 697780576HSTAALIBMDK EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
New Device
Yes
EUDAMED
Aa05-01-24s by Shenzhen Health SwifTech 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 | 697780576HSTAALIBMDK | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Health SwifTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000044339
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED b6681e34-56e8-4d1e-9244-c4f5cc103e75 61 fields · synced Sep 30, 2026