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SILICONE Foley Balloon Catheter
EUDAMEDClass IIb (EU MDR)
Ref 65 20 20Ref 65 20 16Ref 65 20 14Ref 65 20 12
Identity
- Trade Name
- SILICONE Foley Balloon Catheter EUDAMED
- Device Name
- SILICONE Foley Balloon Catheter EUDAMED
- Model / Reference
- 65 20 20 EUDAMED65 20 16 EUDAMED65 20 14 EUDAMED65 20 12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182609051 EUDAMED14711182609037 EUDAMED14711182609020 EUDAMED14711182609013 EUDAMED
- Basic UDI-DI
- B-14711182609051 EUDAMEDB-14711182609037 EUDAMEDB-14711182609020 EUDAMEDB-14711182609013 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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 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-14711182609051 | 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 (4)
- EUDAMED 58b48bf0-90b1-479a-87f1-98510593af9f 61 fields · synced Jul 25, 2026
- EUDAMED cf2305aa-a7bf-44b3-8862-b1c6588a05bb 61 fields · synced May 18, 2026
- EUDAMED 854fe260-7554-47dd-ae21-f2aa71e4d0fc 61 fields · synced May 18, 2026
- EUDAMED 62c0d753-5610-4102-a591-ccb90bda6bc5 61 fields · synced Jul 25, 2026