Identity
- Device Name
- Wound Plaster EUDAMED
- Model / Reference
- Rule 4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974712702153 EUDAMED
- Basic UDI-DI
- 697471270TBCKT1P2 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER 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
Wound Plaster 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 | 697471270TBCKT1P2 | 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 7ea8088c-70d6-4bb7-ac99-ce26080809f3 61 fields · synced Jun 18, 2026