Identity
- Device Name
- Frame EUDAMED
- Model / Reference
- RP-FM-1004 EUDAMEDRP-FM-1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05065024143077 EUDAMED05065024143060 EUDAMED
- Basic UDI-DI
- 5065024143RP-FMSK EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
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
Frame by AA Sales 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 | 5065024143RP-FMSK | Class I | Active |
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Manufacturer
- Manufacturer
- AA Sales Ltd
- EUDAMED SRN
- UK-MF-000047880
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 44472cf8-3623-44bb-abc5-6013f4aa192a 61 fields · synced Jul 22, 2026
- EUDAMED cdc4e12b-64a3-47d4-af59-9baebe8e614f 61 fields · synced May 19, 2026