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Ultramed Flow Regulator
EUDAMEDClass IIa (EU MDR)
Ref 1010Model ULTRAMED FLOW REGULATOR
Identity
- Trade Name
- ULTRAMED FLOW REGULATOR EUDAMED
- Device Name
- ULTRAMED FLOW REGULATOR EUDAMED
- Model / Reference
- ULTRAMED FLOW REGULATOR EUDAMED1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251641 EUDAMED
- Basic UDI-DI
- 622300425FR1010L7 EUDAMEDB-06223004251641 EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS 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
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ultramed Flow Regulator by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 622300425FR1010L7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425FR1010L7 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED a3428431-4083-487e-b811-3091a9a1d3c9 61 fields · synced Oct 6, 2026
- EUDAMED 833a9e03-4105-41c9-bec5-f679473483c8 61 fields · synced May 19, 2026