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Plaster
EUDAMEDClass I (EU MDR)
Ref PL4000Model 72x19mm, 56x19mm, 45x19mm, 40x10mm, 72x25mm, 76x38mm, 60x60mm, 63x25mm, 57x16mm, 76x19mm, 76x25mm, 38x32mm, 38x38mm, 120x20mm, 6cmx1m, 6x10cm, 6cmx5m, φ35,45mm, etc.
Identity
- Trade Name
- Plaster EUDAMED
- Device Name
- Adhesive Plaster EUDAMED
- Model / Reference
- 72x19mm, 56x19mm, 45x19mm, 40x10mm, 72x25mm, 76x38mm, 60x60mm, 63x25mm, 57x16mm, 76x19mm, 76x25mm, 38x32mm, 38x38mm, 120x20mm, 6cmx1m, 6x10cm, 6cmx5m, φ35,45mm, etc. EUDAMEDPL4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05706636599561 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IN0000024L EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Plaster 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 | 69228209MDN1204IN0000024L | 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 1470f053-7de3-44eb-9f93-74e80949ce92 61 fields · synced Jun 18, 2026