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Ultramed I.V. Infusion Set with Flow Regulator
EUDAMEDClass IIa (EU MDR)
Ref 1013
Identity
- Trade Name
- Ultramed I.V. Infusion Set with Flow Regulator EUDAMED
- Device Name
- Ultramed I.V. Infusion Set With Flow Regulator EUDAMEDI.V. INFUSION SET EUDAMED
- Model / Reference
- 1013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004250132 EUDAMED
- Basic UDI-DI
- B-06223004250132 EUDAMED622300425IVS1009Z3 EUDAMED
- EMDN Code
- A03010103 INFUSION CONTROLLERS WITH FLOW REGULATOR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultramed I.V. Infusion Set with Flow Regulator by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDR, MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06223004250132 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06223004250132 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 5af9d20e-f210-4fdb-ab36-9802ae4ea4e4 61 fields · synced Oct 7, 2026
- EUDAMED 0e8767ab-a6d3-4e37-a9f3-15f7c3ca551f 61 fields · synced May 19, 2026