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Silicone 2-way Foley Balloon Catheter, Female
EUDAMEDClass IIb (EU MDR)
Ref 1827-0020Ref 1827-0016
Identity
- Trade Name
- Silicone 2-way Foley Balloon Catheter,Female EUDAMED
- Device Name
- Silicone 2-way Foley Balloon Catheter,Female EUDAMED
- Model / Reference
- 1827-0020 EUDAMED1827-0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14711182628557 EUDAMED14711182628571 EUDAMED
- Basic UDI-DI
- B-14711182628557 EUDAMEDB-14711182628571 EUDAMED
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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, Female 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-14711182628557 | 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 (2)
- EUDAMED a6d90684-d88b-4263-ba88-f3159c41bb12 61 fields · synced Jul 31, 2026
- EUDAMED d9c743bb-b27c-4f2a-9741-0e3cc772994d 61 fields · synced May 18, 2026