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Sterile Adhesive Plaster
EUDAMEDClass I (EU MDR)
Ref FA200-9028Model 7.2 x 1.9 cm, 7.2 x 2.5 cm, 5.6x 1.9cm, etc.
Identity
- Trade Name
- Sterile Adhesive Plaster 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. EUDAMEDFA200-9028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820990283 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS0000337L EUDAMED
- Unit of Use DI
- 86922820990289 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER 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
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
Sterile Adhesive 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 | 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 a9633157-abb1-4f6a-8a72-2cb6c608433e 61 fields · synced Jun 19, 2026