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Disposable sampling swab
EUDAMEDClass I (EU MDR)
Ref ST001-2Model ST001-1, ST001-2, ST001-3，ST001-4, ST001-5
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 EUDAMEDST001-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564731 EUDAMED
- Basic UDI-DI
- 69745415618XU EUDAMED
- Direct Marketing DI
- 06974541564731 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable sampling swab by Bioteke Corporation (Wuxi) Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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 (1)
- EUDAMED ffef00c3-e0e6-419e-83ca-2a0ae5a02344 61 fields · synced Jun 18, 2026