Identity
- Device Name
- Wound Dressing EUDAMED
- Model / Reference
- Rule 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974712705000 EUDAMED
- Basic UDI-DI
- 697471270TBFL01LK EUDAMED
- Direct Marketing DI
- 06974712705000 EUDAMED
- EMDN Code
- M0202020202 NON-WOVEN LAPAROTOMY GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Wound Dressing 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 | 697471270TBFL01LK | 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 bc698293-01d2-4b31-987a-3ea39e17c267 61 fields · synced Jun 18, 2026