Identity
- Trade Name
- OXY SET EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- SH-2016S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265020144 EUDAMED08907265020083 EUDAMED08907265020151 EUDAMED08907265020120 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
Oxy Set 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 (4)
- EUDAMED 80ba7b52-ef7a-4583-bb97-ea483123ae51 61 fields · synced Jul 25, 2026
- EUDAMED ebfb0a2b-e476-476b-a2a8-fa6a42dc2d74 61 fields · synced May 17, 2026
- EUDAMED 4e8890da-7c55-4b02-9230-c3a7ae84fedb 61 fields · synced May 18, 2026
- EUDAMED 98edca0c-2e24-43e8-9692-e2a236a9e9e7 61 fields · synced May 19, 2026