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Silicone 2-way Foley Balloon Catheter
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1821-0506
Identity
- Trade Name
- Silicone 2-way Foley Balloon Catheter EUDAMEDSilicone 2-way Foley Balloon Catheter (Standard Balloon) FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Silicone 2-way Foley Balloon Catheter EUDAMED
- Model / Reference
- 1821-0506 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710961931706 EUDAMEDFDA UDI
- Basic UDI-DI
- 471096193020101F2 EUDAMED
- Direct Marketing DI
- 04710961931706 EUDAMED
- 510(k) Number
- K980919 FDA UDI
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- U020299 URETERAL CATHETERS WITH BALLOON - OTHER EUDAMED
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone 2-way Foley Balloon Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471096193020101F2 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 471096193020101F2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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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 7c01e1f9-918b-4e24-a105-44e32c9a8383 61 fields · synced May 30, 2026
- FDA UDI 2b704d02-5ade-4399-93bc-6134dc27ad52 33 fields · synced May 30, 2026