Disposable Sterile Sampling Swab
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- BioTeke FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Device Name
- Disposable Sterile Sampling Swab EUDAMED
- Model / Reference
- SS001-1, SS001-2, SS001-3, SS001-4, SS001-5, SS001-6, SS001-7 EUDAMEDSS001-7 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974541563307 EUDAMEDFDA UDI
- Basic UDI-DI
- 697454156001KT EUDAMED
- FDA Product Code
- KXG FDA UDI
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
- GMDN Term
- Oral/upper respiratory tract specimen collection swab FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General-purpose absorbent tip applicator/swab, single-use
Disposable Sterile Sampling Swab by Bioteke Corporation (Wuxi) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697454156001KT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 840deab2-8a31-40cb-b39a-dacc288a565b 61 fields · synced Jun 18, 2026
- FDA UDI 643cb7e1-b87a-4ccc-bec0-4c3af084bdf1 32 fields · synced May 29, 2026