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Foam underwrap
EUDAMEDClass I (EU MDR)
Ref 7cmx27m skin colorModel prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size
Identity
- Device Name
- Foam underwrap EUDAMED
- Model / Reference
- prewrap pretape foam bandage foam underwrap bandage under tape foam wrap Underwrap Foam Bandage Underwrap Tape pre-tape 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size 6cm*20m, 7cm*20m, 6cm*27m, 7cm*27m, or customized size EUDAMED7cmx27m skin color EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938799205327 EUDAMED
- Basic UDI-DI
- 69387992FoamunderwrapEL EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Foam underwrap by Wuxi Wemade Healthcare Products 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 | 69387992FoamunderwrapEL | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Wemade Healthcare Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009786
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED fd7be8fc-dfa2-4aa4-85fa-568e8470a1cb 61 fields · synced Oct 7, 2026