Identity
- Trade Name
- RMS EUDAMEDRMS VENTED INFUSION SET EUDAMED
- Device Name
- BLOOD ADMINISTRATION SET (TRANSFUSION SET) EUDAMEDINFUSION SET EUDAMED
- Model / Reference
- SS-3052 EUDAMEDSS 3060 KAD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265305203 EUDAMED08907265011005 EUDAMED
- Basic UDI-DI
- 8907265D001YQ EUDAMED8907265C014YS EUDAMED
- EMDN Code
- B010201 WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS EUDAMEDA03010103 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 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 | 8907265D001YQ | 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 dd4ec1ab-21fa-4bd4-a2d5-45780565fd2d 61 fields · synced Jul 17, 2026
- EUDAMED 2c3814a9-e37f-405f-9d5f-02ccaff0f7ca 61 fields · synced May 18, 2026