Identity
- Trade Name
- HI-MASK EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- GS-2044S EUDAMEDGS-2044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120204448 EUDAMED08902120204417 EUDAMED08902120204424 EUDAMED08902120204431 EUDAMED
- Basic UDI-DI
- 8902120B014RQ EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Hi-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 (4)
- EUDAMED 47e9696c-06d9-4185-a9e5-f360d8ab4a35 61 fields · synced Jul 29, 2026
- EUDAMED 0518ef89-318a-416f-98a0-20c3fe1ca774 61 fields · synced May 18, 2026
- EUDAMED 82ebcc88-e039-4986-a115-060724ed2696 61 fields · synced May 19, 2026
- EUDAMED de3a669c-55de-41c0-8f5b-d99ba5bc4be8 61 fields · synced May 19, 2026