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Disposable Sampling Swab
EUDAMEDClass I (EU MDR)
Ref 3982812Model NPRRef 3982872Model NSBRRef 3982821Model OPRRef 3982882Model NPBRRef 3982881Ref 3982822
Identity
- Trade Name
- Disposable Sampling Swab EUDAMED
- Device Name
- Disposable Sampling Swab EUDAMED
- Model / Reference
- NPR EUDAMED3982812 EUDAMEDNSBR EUDAMED3982872 EUDAMEDOPR EUDAMED3982821 EUDAMEDNPBR EUDAMED3982882 EUDAMED3982881 EUDAMED3982822 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16977644787486 EUDAMED16977644787523 EUDAMED16973471960863 EUDAMED16977644787493 EUDAMED16973471960849 EUDAMED16977644787509 EUDAMED
- Basic UDI-DI
- 6973471963982813U EUDAMED69734719639828748 EUDAMED6973471963982823W EUDAMED6973471963982884A EUDAMED
- Unit of Use DI
- 06973471960828 EUDAMED06973471960903 EUDAMED06973471960866 EUDAMED06973471960842 EUDAMED
- EMDN Code
- A1101 SAMPLE COLLECTION NEUTRAL SWABS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Disposable Sampling Swab by Shenzhen Dakewe Bio-Engineering 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 | 6973471963982813U | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (6)
- EUDAMED 44737133-da71-422c-b6bc-db1c54b794d1 61 fields · synced Jul 19, 2026
- EUDAMED d60ee345-8235-4bde-8a2b-580846ba0623 61 fields · synced May 16, 2026
- EUDAMED f50fc35b-a6ad-4ba9-8394-d9a26717af0a 61 fields · synced May 17, 2026
- EUDAMED fab344c9-4ee8-479f-9678-8dde8f46d66e 61 fields · synced May 17, 2026
- EUDAMED c80482fc-f423-4fd4-bee5-4a2ac41b2212 61 fields · synced May 17, 2026
- EUDAMED 5e5cfbc4-a0ec-4ccf-a75d-bf5a6c07a44c 61 fields · synced May 19, 2026