Identity
- Trade Name
- EO sterile non-woven swabs EUDAMED
- Device Name
- Non-woven sponges without X-ray detectable thread EUDAMED
- Model / Reference
- 15842125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490851954 EUDAMED
- Basic UDI-DI
- 697349085UMNWSYC EUDAMED
- EMDN Code
- M0202030101 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
EO sterile non-woven swabs by Unimax Medical Products 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 | 697349085UMNWSYC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6b12c110-3b9d-4a53-b105-fe3150bddc6d 61 fields · synced Oct 6, 2026