← Back to catalogue
Disposable sampling swab
EUDAMEDClass I (EU MDR)
Ref ST001-1, ST001-2, ST001-3，ST001-4, ST001-5Ref ST001-1
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 EUDAMEDST001-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541564724 EUDAMED
- Basic UDI-DI
- 69745415618XU EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDCyprus 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.
- Disposable Sterile Swabs — Hangzhou Yiguoren Biotechnology Co.,Ltd. · Class I
- NATIONAL HOSPITAL PACKAGING — Surgi-Pak, Inc. · Class I
- Disposable Collection Tubes of Virus Samples — Jiangsu Mole Bioscience Co., LTD. · Class A
- ESCOB. PS FLOCK NASOF. 80MM EN TUBO — Deltalab, S.L. · Class IIa
- Disposable sampling swab — Jiangsu HanHeng Medical Technology Co., Ltd. · Class I
- Microbrush — YOUNG MICROBRUSH LLC · Class I
- CITOTEST — CITOTEST LABWARE MANUFACTURING CO.,LTD · Class I
- ESCOB.FLOCK NASOF. 80MM FLOW — Deltalab, S.L. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 81afb8c9-dc8a-4624-ae60-b3c9f46b0012 61 fields · synced Jun 19, 2026
- EUDAMED 81afb8c9-dc8a-4624-ae60-b3c9f46b0012-1 61 fields · synced Jun 9, 2026
- EUDAMED dd6950d8-2327-4032-9013-c4cfff74522c 61 fields · synced Jun 19, 2026