Identity
- Trade Name
- RMS INFUSION SET EUDAMED
- Device Name
- INFUSION SET EUDAMED
- Model / Reference
- SS-3062 EUDAMEDSS-3062 KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265306200 EUDAMED08907265013030 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
Rms Infusion Set 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 (2)
- EUDAMED 52da3915-5605-4243-8eac-9b4ad99f1861 61 fields · synced Jul 20, 2026
- EUDAMED 1e1d1e5b-18fd-4c16-bd00-f13ef6743792 61 fields · synced Jul 20, 2026