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38x4mm Wound Skin Closure Strip
EUDAMEDClass I (EU MDR)
Ref FA200-9173Model 38~100 * 3~12mm
Identity
- Trade Name
- 38x4mm Wound Skin Closure Strip EUDAMED
- Device Name
- Wound Skin Closure Strip EUDAMED
- Model / Reference
- 38~100 * 3~12mm EUDAMEDFA200-9173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991730 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000507L EUDAMED
- EMDN Code
- M04010201 NON-WOVEN FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
38x4mm Wound Skin Closure Strip by RFX+CARE Manufacturing 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 | 69228209MDN1204IS0000507L | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED a9a36fea-6533-4697-bf85-fabe97b48ea4 61 fields · synced Jun 19, 2026