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Gauze Sponges without X-ray Detectable Thread
EUDAMEDClass IIa (EU MDR)
Ref 1205
Identity
- Trade Name
- Gauze Sponges without X-ray Detectable Thread EUDAMED
- Device Name
- Gauze sponges EUDAMED
- Model / Reference
- 1205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490858793 EUDAMED
- Basic UDI-DI
- 697349085UMGSOWM EUDAMED
- Direct Marketing DI
- 06973490858793 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Gauze Sponges without X-ray Detectable Thread by Unimax Medical Products Co., Ltd. — Class IIa — 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 | 697349085UMGSOWM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 47b8ba85-584a-4a51-b67f-e4911259bc85 61 fields · synced Oct 6, 2026