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Sterile wound plaster
EUDAMEDClass I (EU MDR)
Ref UM-NWSS-001-17Ref 15910142Ref 15910140
Identity
- Trade Name
- Sterile wound plaster EUDAMEDPlaster EUDAMED
- Device Name
- Sterile wound plaster EUDAMED
- Model / Reference
- UM-NWSS-001-17 EUDAMED15910142 EUDAMED15910140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490857826 EUDAMED06973490853491 EUDAMED06973490853453 EUDAMED
- Basic UDI-DI
- 697349085UMSWPYX EUDAMED
- Direct Marketing DI
- 06973490857826 EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDFinland 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
Sterile wound plaster by Unimax Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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 | 697349085UMSWPYX | Class I | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 62cac3b3-21fe-4adf-870e-f94995df42e9 61 fields · synced Oct 6, 2026
- EUDAMED f29a05e2-f359-4d1a-9e63-228287933c15 61 fields · synced Jul 17, 2026
- EUDAMED a38dcf1a-02a9-4748-a7b7-cdf8620eafe0 61 fields · synced Jul 20, 2026