Identity
- Trade Name
- Silicone 2-way Foley Balloon Catheter EUDAMED
- Device Name
- Silicone 2-way Foley Balloon Catheter EUDAMED
- Model / Reference
- 1822-0522 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961931925 EUDAMED
- Basic UDI-DI
- B-14710961931925 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone 2-way Foley Balloon Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14710961931925 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 4725ffbf-0cfd-4830-ab11-a0446fcf84fd 61 fields · synced May 23, 2026