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Sample Preservation Solution
EUDAMEDClass A (EU MDR)
Ref ST7001-3Model ST7001-3, ST8001-3, ST9001-3Ref ST9001-3
Identity
- Device Name
- Sample Preservation Solution EUDAMED
- Model / Reference
- ST7001-3, ST8001-3, ST9001-3 EUDAMEDST7001-3 EUDAMEDST9001-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541563185 EUDAMED06974541564847 EUDAMED
- Basic UDI-DI
- 697454156005L3 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMEDFinland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Sample Preservation Solution by Bioteke Corporation (Wuxi) 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 | 697454156005L3 | Class A | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 0afc07ee-4d09-40d5-9936-0b83eff9badc 61 fields · synced Oct 6, 2026
- EUDAMED 6166c4e1-9537-4106-8790-ccadf15e2858 61 fields · synced Jul 26, 2026