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Sfa
EUDAMEDClass I (EU MDR)
Ref D8105 HYPACOVER TRAUMA DRESSINGModel All SizesRef D8104 HYPACOVER TRAUMA DRESSING
Identity
- Trade Name
- SFA EUDAMED
- Model / Reference
- All Sizes EUDAMEDD8105 HYPACOVER TRAUMA DRESSING EUDAMEDD8104 HYPACOVER TRAUMA DRESSING EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864851887 EUDAMED06973864851870 EUDAMED
- Basic UDI-DI
- 697386485FABandageUM EUDAMED
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Sfa 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 | 697386485FABandageUM | 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 (2)
- EUDAMED 7a5e4d61-c3ac-46c3-b7bd-0862f0f7aa9e 61 fields · synced Oct 6, 2026
- EUDAMED dbdf355b-adc5-4520-b49d-c86bdc1b9c4e 61 fields · synced May 18, 2026