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00646 ISLAND DRESSINGIN TNT 10*15CM, box of 3pcs, 12boxes/tray
EUDAMEDClass I (EU MDR)
Ref 00646Model All Sizes
Identity
- Trade Name
- 00646 ISLAND DRESSINGIN TNT 10*15CM, box of 3pcs, 12boxes/tray EUDAMED
- Device Name
- Wound Dressing/Plaster Strips/Wound Plaster EUDAMED
- Model / Reference
- All Sizes EUDAMED00646 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864859654 EUDAMED
- Basic UDI-DI
- 697386485WoundPlasterX7 EUDAMED
- Direct Marketing DI
- 06973864859654 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
00646 ISLAND DRESSINGIN TNT 10*15CM, box of 3pcs, 12boxes/tray 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 ac14d63c-64b4-430b-999d-589ecbbb3d97 61 fields · synced Oct 6, 2026