Identity
- Trade Name
- Sampling Swab EUDAMED
- Device Name
- Sampling Swab EUDAMED
- Model / Reference
- A111116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698601009 EUDAMED
- Basic UDI-DI
- 697269860SAM001QT EUDAMED
- Unit of Use DI
- 06972698601002 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS 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
Sampling Swab 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 | 697269860SAM001QT | 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 f40db38d-99db-4e3e-a2c9-8b3700d9c40f 61 fields · synced Jun 20, 2026