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Disposable Virus Sampling Swab Kits
EUDAMEDClass A (EU MDR)
Ref ST9001-1Model ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2
Identity
- Device Name
- Disposable Virus Sampling Swab Kits EUDAMED
- Model / Reference
- ST7001-0, ST7001-1, ST7001-2, ST8001-0, ST8001-1, ST8001-2, ST9001-0, ST9001-1, ST9001-2 EUDAMEDST9001-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564915 EUDAMED
- Basic UDI-DI
- 697454156004KZ EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland 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
Disposable Virus Sampling Swab Kits 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 | 697454156004KZ | 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 (1)
- EUDAMED 4ad85fcb-7d5e-45b1-af74-a6168360af3e 61 fields · synced Jun 14, 2026