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00654 WATERPROOF ADHESIVE DRESSING 8×10cm (XL), box of 4pcs
EUDAMEDClass I (EU MDR)
Ref 00654Model All Sizes
Identity
- Trade Name
- 00654 WATERPROOF ADHESIVE DRESSING 8×10cm (XL), box of 4pcs EUDAMED
- Device Name
- Wound Dressing/Plaster Strips/Wound Plaster EUDAMED
- Model / Reference
- All Sizes EUDAMED00654 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942694602457 EUDAMED
- Basic UDI-DI
- 697386485WoundPlasterX7 EUDAMED
- Direct Marketing DI
- 06942694602457 EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
00654 WATERPROOF ADHESIVE DRESSING 8×10cm (XL), box of 4pcs by Suzhou Sunmed 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 | 697386485WoundPlasterX7 | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED c650f44b-c044-4750-9605-505b500b89cd 61 fields · synced Oct 6, 2026