Identity
- Trade Name
- PLEISTERS EUDAMED
- Device Name
- Plaster（nonwoven fabric) EUDAMEDSterile Adhesive Plaster（nonwoven fabric) EUDAMED
- Model / Reference
- 709841 EUDAMED709842 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05400519001836 EUDAMED05400519001829 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000735B EUDAMED69228209MDN1204IS00008383 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Pleisters 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 | 69228209MDN1204IN0000735B | 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 (2)
- EUDAMED eed53554-9d87-4484-bb0c-b75f5b8d765e 61 fields · synced Sep 18, 2026
- EUDAMED 6fd48e15-9f6e-4f27-bcbe-43609b4c60b1 61 fields · synced May 19, 2026