Identity
- Trade Name
- TRANSFUSION SETS FOR SINGLE USE EUDAMED
- Device Name
- BLOOD ADMINISTRATION SET (TRANSFUSION SET) EUDAMED
- Model / Reference
- SS-3088 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265308808 EUDAMED
- Basic UDI-DI
- 8907265D001YQ EUDAMED
- EMDN Code
- B010201 WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS 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
Transfusion Sets For Single Use 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 (1)
- EUDAMED bbc9c8f7-fdee-42a9-9b2c-3b651688fb8e 61 fields · synced Jul 15, 2026