Identity
- Trade Name
- ROMO DRIP EUDAMED
- Device Name
- INFUSION SET EUDAMED
- Model / Reference
- SS-3506 EUDAMEDSS-3509 EUDAMEDSS-3509N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265350609 EUDAMED08907265350906 EUDAMED08907265350913 EUDAMED
- Basic UDI-DI
- 8907265C014YS EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Romo Drip 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 | 8907265C014YS | 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 (3)
- EUDAMED 48c74364-efcd-4a0c-933c-c17db2a2ce68 61 fields · synced Jul 26, 2026
- EUDAMED cd865cbb-5a34-4fb2-a530-20c2353b737e 61 fields · synced May 17, 2026
- EUDAMED f7f9bcb5-c7f5-4b28-a93d-28aa9f9d7337 61 fields · synced May 18, 2026