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ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 10 FG / 2-WAY
EUDAMEDClass IIa (EU MDR)
Ref 3007-10/2Model ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 10 FG / 2-WAY Model ULTRAMED SILICONE FOLEY BALLOON CATHETER
Identity
- Trade Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 10 FG / 2-WAY EUDAMED
- Device Name
- ULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED
- Model / Reference
- ULTRAMED SILICONE FOLEY BALLOON CATHETER Size 10 FG / 2-WAY EUDAMED3007-10/2 EUDAMEDULTRAMED SILICONE FOLEY BALLOON CATHETER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251344 EUDAMED
- Basic UDI-DI
- B-06223004251344 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 10 FG / 2-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-06223004251344 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06223004251344 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 20121e87-d018-4700-9835-011aa0a3e87a 61 fields · synced Oct 10, 2026
- EUDAMED 775608e1-b34f-4664-b4ed-e10f3082f439 61 fields · synced May 19, 2026