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ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 18 FG / 3-WAY
EUDAMEDClass IIa (EU MDR)
Ref 3007-18/3Model ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 18 FG / 3-WAY Model ULTRAMED SILICONE FOLEY BALLOON CATHETER
Identity
- Trade Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 18 FG / 3-WAY EUDAMED
- Device Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED
- Model / Reference
- ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 18 FG / 3-WAY EUDAMED3007-18/3 EUDAMEDULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251436 EUDAMED
- Basic UDI-DI
- B-06223004251436 EUDAMED622300425SFC3007SP 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 18 FG / 3-WAY 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-06223004251436 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06223004251436 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 0f69e14c-002c-431a-af4e-b9c8ea976d20 61 fields · synced Oct 6, 2026
- EUDAMED dba2541b-fa9c-4d32-8d45-7313c365bdc6 61 fields · synced May 19, 2026