Identity
- Trade Name
- ROMO VENTE EUDAMED
- Device Name
- BAIN CIRCUIT EUDAMED
- Model / Reference
- SH-2089 EUDAMEDSH-2088 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265208900 EUDAMED08907265208801 EUDAMED
- Basic UDI-DI
- 8907265B025YQ EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Romo Vente 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 | 8907265B025YQ | 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 331dd2ee-90fa-4c1e-9610-1a474882f39e 61 fields · synced Aug 1, 2026
- EUDAMED 9b9e599f-1731-4665-b395-39f9f137dd7e 61 fields · synced May 18, 2026