Identity
- Trade Name
- INTRACARE EUDAMEDINTRASAFE EUDAMED
- Device Name
- INFUSION SET EUDAMEDINTRAVENOUS CANNULA EUDAMED
- Model / Reference
- SS-3099 EUDAMEDGS-3223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265309904 EUDAMED08907265322309 EUDAMED08907265322330 EUDAMED08907265322347 EUDAMED
- Basic UDI-DI
- 8907265C014YS EUDAMED8907265C001YH EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMEDC0101010201 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, WITH INJECTION VALVES 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intracare 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 (4)
- EUDAMED 5990ec51-1372-439b-8dbf-358d115d652e 61 fields · synced Sep 18, 2026
- EUDAMED 7fb83581-aa43-43e8-a08c-f0ec78854073 61 fields · synced Jul 22, 2026
- EUDAMED 215848b8-e3c9-47e9-af66-a34b29ceb868 61 fields · synced Jul 29, 2026
- EUDAMED d25658e4-d307-4432-8de4-1104541d9584 61 fields · synced Sep 18, 2026