Identity
- Trade Name
- FLEXI MASK EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- GS-2020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120202017 EUDAMED08902120202024 EUDAMED
- Basic UDI-DI
- 8902120B014RQ EUDAMED
- EMDN Code
- R03010202 VENTURI MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Flexi Mask by Romsons International (Unit II) — Class IIa — 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 | 8902120B014RQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED c65f64ed-4564-41fd-98b0-83c3473cea02 61 fields · synced Jul 22, 2026
- EUDAMED eb5cec25-ef01-4016-bac1-f705375271a8 61 fields · synced May 19, 2026