Identity
- Device Name
- Gauze Sponges EUDAMED
- Model / Reference
- rule 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974712702535 EUDAMED
- Basic UDI-DI
- 697471270TBSBP1QR EUDAMED
- EMDN Code
- M0202030101 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE 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
Gauze Sponges by Ningbo Tianbo First Aid Product 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 | 697471270TBSBP1QR | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Tianbo First Aid Product Co., Ltd.
- EUDAMED SRN
- CN-MF-000016721
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 4c0bfa74-1686-43dd-a70b-654fba8ee380 61 fields · synced Jun 19, 2026