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ULTRAMED I.V. INFUSION SET With Air-vented Spike
EUDAMEDClass IIa (EU MDR)
Ref 1014
Identity
- Trade Name
- ULTRAMED I.V. INFUSION SET With Air-vented Spike EUDAMED
- Device Name
- I.V. INFUSION SET EUDAMEDUktramed I.V. Infusion Set With Air-Vented Spike EUDAMED
- Model / Reference
- 1014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251917 EUDAMED
- Basic UDI-DI
- 622300425IVS1009Z3 EUDAMEDB-06223004251917 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET 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 Air-vented Spike by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed in EUDAMED
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 | 622300425IVS1009Z3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425IVS1009Z3 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d2b11614-662d-4fff-bae9-45bf3abd66eb 61 fields · synced Oct 6, 2026
- EUDAMED 91f18943-2509-4814-b920-47b386c5af7a 61 fields · synced May 18, 2026