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ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 20 FG / 3-WAY
EUDAMEDClass IIa (EU MDR)
Ref 3007-20/3Model ULTRAMED SILICONE FOLEY BALLOON CATHETERModel ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 20 FG / 3-WAY
Identity
- Trade Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 20 FG / 3-WAY EUDAMED
- Device Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED
- Model / Reference
- ULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED3007-20/3 EUDAMEDULTRAMED SILICONE FOLEY BALLOON CATHETER Size 20 FG / 3-WAY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251443 EUDAMED
- Basic UDI-DI
- 622300425SFC3007SP EUDAMEDB-06223004251443 EUDAMED
- EMDN Code
- U010201,U010299 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 20 FG / 3-WAY 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 | 622300425SFC3007SP | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425SFC3007SP | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED c394c405-1e78-42b9-b82e-a1c3fa0c6316 61 fields · synced Oct 6, 2026
- EUDAMED 1384155b-671a-49bd-a1d5-47e732f52191 61 fields · synced May 19, 2026