Identity
- Trade Name
- OXY LOCK EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- SH-2038S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265203837 EUDAMED08907265203820 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 Lock 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 9e57e52b-a317-47e9-a82b-63551d14507d 61 fields · synced Jul 17, 2026
- EUDAMED a18e26ab-e78e-4682-8f1e-17d22c40524f 61 fields · synced May 19, 2026