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Disposable sampling swab
EUDAMEDClass I (EU MDR)
Ref ST001-5Model ST001-1, ST001-2, ST001-3，ST001-4, ST001-5Ref ST001-4Ref ST001-3
Identity
- Trade Name
- Disposable sampling swab EUDAMED
- Device Name
- Disposable sampling swab EUDAMED
- Model / Reference
- ST001-1, ST001-2, ST001-3，ST001-4, ST001-5 EUDAMEDST001-5 EUDAMEDST001-4 EUDAMEDST001-3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564762 EUDAMED06974541564755 EUDAMED06974541564748 EUDAMED
- Basic UDI-DI
- 69745415618XU EUDAMED
- Direct Marketing DI
- 06974541564762 EUDAMED06974541564755 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDFinland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable sampling swab by Bioteke Corporation (Wuxi) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69745415618XU | Class I | 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 (3)
- EUDAMED 5bf23478-fd28-471d-98d8-28713128a3e3 61 fields · synced Oct 6, 2026
- EUDAMED 21a52aa4-907a-41e3-b5ac-df8a5d28263d 61 fields · synced May 17, 2026
- EUDAMED 4bf0de81-dca4-436e-965f-c5879401d2e1 61 fields · synced May 19, 2026