Identity
- Trade Name
- BacTrans Swabs EUDAMED
- Device Name
- BacTrans Swabs EUDAMED
- Model / Reference
- M221101 EUDAMEDM221110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698602976 EUDAMED
- Basic UDI-DI
- 697269860BTM001QF EUDAMED
- Direct Marketing DI
- 16972698602976 EUDAMED
- EMDN Code
- A1102 SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
BacTrans Swabs by Hangzhou Genesis Biodetection and Biocontrol 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 | 697269860BTM001QF | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 78adfbbc-a903-4eef-b952-165ba34b723e 61 fields · synced Jun 18, 2026