Identity
- Trade Name
- BacTrans Swabs EUDAMED
- Device Name
- BacTrans Swabs EUDAMED
- Model / Reference
- M221101 EUDAMEDM221109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698602969 EUDAMED
- Basic UDI-DI
- 697269860BTM001QF EUDAMED
- Direct Marketing DI
- 16972698602969 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
BacTrans Swabs by Hangzhou Genesis Biodetection and Biocontrol 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 | 697269860BTM001QF | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fdd1adbc-55a6-4352-9a5c-4ca585b70ea4 61 fields · synced Jun 19, 2026