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Full Automatic Sample Transfer Processing System
EUDAMEDClass A (EU MDR)
Ref AiStar 770Model AiStar 670, AiStar 770
Identity
- Trade Name
- Full Automatic Sample Transfer Processing System EUDAMED
- Device Name
- Full Automatic Sample Transfer Processing System EUDAMED
- Model / Reference
- AiStar 670, AiStar 770 EUDAMEDAiStar 770 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974621212453 EUDAMED
- Basic UDI-DI
- 697462121AiStar5F EUDAMED
- Direct Marketing DI
- 06974621212453 EUDAMED
- EMDN Code
- W02060102 AUTOMATED SAMPLE TRANSPORT SYSTEMS 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
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
Full Automatic Sample Transfer Processing System by Aikang MedTech 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 | 697462121AiStar5F | Class A | Active |
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Manufacturer
- Manufacturer
- Aikang MedTech Co., Ltd
- EUDAMED SRN
- CN-MF-000027272
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 884d32eb-2382-47df-af45-0d1d5074fd6b 61 fields · synced Jul 29, 2026