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PAILLETTES Pansements
EUDAMEDClass I (EU MDR)
Ref 604582Model 7.2 x 1.9 cm, 7.2 x 2.5 cm, 5.6x 1.9cm, etc.
Identity
- Trade Name
- PAILLETTES Pansements EUDAMED
- Device Name
- Sterile Adhesive Plaster EUDAMED
- Model / Reference
- 7.2 x 1.9 cm, 7.2 x 2.5 cm, 5.6x 1.9cm, etc. EUDAMED604582 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03664492022413 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000337L EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
PAILLETTES Pansements 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 | 69228209MDN1204IS0000337L | 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 eb3295a1-9328-403c-83ef-2c98e72525af 61 fields · synced Jun 17, 2026