Identity
- Trade Name
- Burn Dressing EUDAMED
- Device Name
- Burn Dressing EUDAMED
- Model / Reference
- TX1234 EUDAMEDTX1235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953102636049 EUDAMED06953102631877 EUDAMED
- Basic UDI-DI
- 69531026BDF0503BSSLS EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
Burn Dressing by Taizhou Xinkang Medical Materials Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 69531026BDF0503BSSLS | Class I | Active |
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Manufacturer
- Manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000012941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED c5fc2563-798f-45c7-9be1-b620ebc9e3fe 61 fields · synced Jul 9, 2026
- EUDAMED df5a8a77-cde3-48bb-995e-bcb66c29a597 61 fields · synced May 18, 2026