Identity
- Trade Name
- FLEXI MASK EUDAMED
- Device Name
- OXYGEN DELIVERY DEVICES EUDAMED
- Model / Reference
- SH-2020S EUDAMEDSH-2020S KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265202045 EUDAMED08907265011081 EUDAMED08907265202038 EUDAMED08907265011067 EUDAMED08907265202069 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
Flexi 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 (5)
- EUDAMED 37d1503b-6efb-4550-a561-38e252fc2f6b 61 fields · synced Jul 17, 2026
- EUDAMED 69d34e87-6062-414e-91ad-222d66d785cc 61 fields · synced May 17, 2026
- EUDAMED cf36458e-22fc-4bc0-b5d5-e2770dcf457e 61 fields · synced May 17, 2026
- EUDAMED 40656ae0-4742-4b85-8c96-16465e07a46a 61 fields · synced May 19, 2026
- EUDAMED 49564492-e33f-4f48-ae17-982dc1a4b2ff 61 fields · synced May 19, 2026