Identity
- Trade Name
- FUSION EUDAMED
- Device Name
- VENTILATOR CIRCUIT EUDAMED
- Model / Reference
- SH-2302 EUDAMEDSH-2301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265230208 EUDAMED08907265230109 EUDAMED
- Basic UDI-DI
- 8907265B012YF 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
Fusion 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 | 8907265B012YF | 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 082fe38c-442b-4916-86ee-e6c524b0237f 61 fields · synced Jul 10, 2026
- EUDAMED 95d6b49f-67eb-415a-9ef6-9be3ff5aa4a5 61 fields · synced May 17, 2026