Identity
- Trade Name
- HI-MASK EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- SH-2044S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265204803 EUDAMED08907265204797 EUDAMED
- Basic UDI-DI
- 8907265B014YK EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Hi-Mask by Romsons Group Private Limited — 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 | 8907265B014YK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 8be3cd75-1500-485f-911a-5d8c0cc59201 61 fields · synced Jul 19, 2026
- EUDAMED 4b641a36-1ee3-42fd-9ee9-e732d96ccd82 61 fields · synced May 19, 2026