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Silicone 3-way Foley Balloon Catheter
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1830-0516Ref 1830-0524Ref 1830-0518Ref 1830-0526Ref 1830-0522Ref 1830-0514
Identity
- Trade Name
- Silicone 3-way Foley Balloon Catheter EUDAMEDSilicone 3-way Foley Balloon Catheter,Female EUDAMEDSilicone 3-way Foley Balloon Catheter (Standard Balloon) FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Silicone 3-way Foley Balloon Catheter EUDAMEDSilicone 3-way Foley Balloon Catheter,Female EUDAMED
- Model / Reference
- 1830-0516 EUDAMED1830-0524 EUDAMED1830-0518 EUDAMED1830-0526 EUDAMEDFDA UDI1830-0522 EUDAMEDFDA UDI1830-0514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961932533 EUDAMED14710961932571 EUDAMED14710961932540 EUDAMED14710961932588 EUDAMED04710961932581 EUDAMEDFDA UDI04710961932567 EUDAMEDFDA UDI14710961932526 EUDAMED
- Basic UDI-DI
- B-14710961932533 EUDAMEDB-14710961932571 EUDAMEDB-14710961932540 EUDAMEDB-14710961932588 EUDAMEDB-04710961932581 EUDAMEDB-04710961932567 EUDAMEDB-14710961932526 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
- Denmark EUDAMEDMalta EUDAMEDNetherlands 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
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
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 3-way Foley Balloon Catheter by Fortune Medical Instrument Corp. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-14710961932533 | 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 (9)
- EUDAMED f077b678-84ea-40cb-8135-62eda4fd130d 61 fields · synced Jul 23, 2026
- EUDAMED 7b00effd-64d1-4ca8-88b9-dd856e9c6133 61 fields · synced May 17, 2026
- EUDAMED e12792d8-88d9-4573-a870-eaad42265777 61 fields · synced May 17, 2026
- EUDAMED 98b3900a-bba4-412f-9230-98455d053839 61 fields · synced May 18, 2026
- EUDAMED 407efb44-a2f0-468e-96eb-0e825c086488 61 fields · synced May 19, 2026
- FDA UDI d0d8249f-1836-46aa-a797-152b61853863 33 fields · synced May 22, 2026
- FDA UDI 45f9ea17-bcbb-400b-8863-b01ae792c5ff 33 fields · synced May 30, 2026
- EUDAMED 503a565d-5e97-41c5-9c34-daa9ad38c495 61 fields · synced Jul 13, 2026
- EUDAMED f9c0f4e1-723f-44fb-8b09-80c3399efd40 61 fields · synced Jul 19, 2026