Identity
- Trade Name
- Blister plaster EUDAMED
- Device Name
- Sterile Blister Plaster EUDAMED
- Model / Reference
- 3.7x5.5cm EUDAMEDFA200-9102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991020 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000367S EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED 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
Blister 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 | 69228209MDN1204IS0000367S | 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 43551307-491c-43a0-94da-521a39a82f5d 61 fields · synced Jun 19, 2026