Identity
- Trade Name
- OXY SET EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- GS-2016 EUDAMEDGS-2016S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120201676 EUDAMED08902120201683 EUDAMED08902120201645 EUDAMED08902120201614 EUDAMED
- Basic UDI-DI
- 8902120B014RQ EUDAMED
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) 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
Oxy Set 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 c38778f5-74ba-4707-b44a-aadb1bfe5348 61 fields · synced Jul 25, 2026
- EUDAMED 14e7bbce-134a-4bcf-8437-66e76083b6a3 61 fields · synced May 17, 2026
- EUDAMED 43bfc0dd-60b5-4fc0-bee9-2b5c6be53dd9 61 fields · synced May 17, 2026
- EUDAMED 06c603ea-381a-42d8-b819-ab5e0859bbc7 61 fields · synced May 19, 2026