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Steriele Wondpleister
EUDAMEDClass I (EU MDR)
Ref 709763Ref 709765Model 5~25x5~30cmRef 709837Ref 709764
Identity
- Trade Name
- STERIELE WONDPLEISTER EUDAMED
- Device Name
- Sterile wound derssing(adhensive) -PU EUDAMEDSterile wound dressing((adhensive)-nonwoven fabric EUDAMED
- Model / Reference
- 709763 EUDAMED5~25x5~30cm EUDAMED709765 EUDAMED709837 EUDAMED709764 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05400519001928 EUDAMED05400519001904 EUDAMED05400519001898 EUDAMED05400519001911 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS00009182 EUDAMED69228209MDN1204IS0000657Z EUDAMED
- EMDN Code
- M04010102 POLYURETHANE (OR OTHER MATERIAL) ADHESIVE DRESSINGS, WITH ABSORBENT PAD EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Steriele Wondpleister 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 | 69228209MDN1204IS00009182 | 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 (4)
- EUDAMED 83f0a6c4-ac69-4631-86a2-388a4267dd5e 61 fields · synced Oct 6, 2026
- EUDAMED 9162c2b6-20cc-4d38-9268-223ca1126b9d 61 fields · synced May 18, 2026
- EUDAMED 068808ca-9318-4b0e-8736-c277ec7e0d35 61 fields · synced May 19, 2026
- EUDAMED e82d7fd3-0b78-426c-a9f7-541d9ee12774 61 fields · synced May 19, 2026