Identity
- Trade Name
- Transparent Dressing EUDAMED
- Device Name
- Transparent Dressing EUDAMED
- Model / Reference
- Type T01 EUDAMEDT016070 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975489891774 EUDAMED
- Basic UDI-DI
- 697548989XLT014R EUDAMED
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Transparent Dressing by Shandong Shinrise Medical Supplies 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 | 697548989XLT014R | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Shinrise Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000031315
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED f6936bf8-a5c5-45ed-99a0-4abb273ec393 61 fields · synced Jun 19, 2026