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ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 8 FG / 2-WAY
EUDAMEDClass IIa (EU MDR)
Ref 3006-8/2Model ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETERModel ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 8 FG / 2-WAY
Identity
- Trade Name
- ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 8 FG / 2-WAY EUDAMED
- Device Name
- ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER EUDAMED
- Model / Reference
- ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER EUDAMED3006-8/2 EUDAMEDULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 8 FG / 2-WAY EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251191 EUDAMED
- Basic UDI-DI
- 622300425LFC3006NW EUDAMEDB-06223004251191 EUDAMED
- EMDN Code
- U010201,U010299 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ULTRAMED SILICONE COATED LATEX FOLEY BALLOON CATHETER Size 8 FG / 2-WAY by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR…
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 | 622300425LFC3006NW | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425LFC3006NW | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1f117baf-601a-4d9c-9304-3a44b9862e14 61 fields · synced Oct 6, 2026
- EUDAMED c51afd97-326d-4ede-b7d3-98aa3752a24e 61 fields · synced May 19, 2026