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Silicone 2-way Foley Balloon Catheter
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1827-0020Ref 4822-0518Ref 1822-0516Ref 4833-0514Ref 1821-0508Ref 1821-0606Ref 4833-0516Ref 1823-0516Ref 1821-0506Ref 1822-0512Ref 4822-0522Ref 4833-0512Ref 1827-0016Ref 1822-0514
Identity
- Trade Name
- Silicone 2-way Foley Balloon Catheter EUDAMEDSilicone 2-way Foley Balloon Catheter (Grooved Balloon) FDA UDISilicone 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
- 1827-0020 EUDAMEDFDA UDI4822-0518 EUDAMED1822-0516 EUDAMED4833-0514 EUDAMED1821-0508 EUDAMEDFDA UDI1821-0606 EUDAMEDFDA UDI4833-0516 EUDAMED1827-0016 EUDAMEDFDA UDI1822-0512 EUDAMEDFDA UDI1823-0516 EUDAMED1821-0506 EUDAMED4822-0522 EUDAMED4833-0512 EUDAMED1822-0514 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182628550 EUDAMEDFDA UDI14710961936548 EUDAMED14710961931895 EUDAMED14711182608085 EUDAMED04710961931713 EUDAMEDFDA UDI04711182607050 EUDAMEDFDA UDI14711182608092 EUDAMED04711182628574 EUDAMEDFDA UDI04710961931874 EUDAMEDFDA UDI14710961932175 EUDAMED14710961931703 EUDAMED14710961931871 EUDAMED14710961936562 EUDAMED14711182608078 EUDAMED14710961931888 EUDAMED
- Basic UDI-DI
- B-04711182628550 EUDAMEDB-14710961936548 EUDAMEDB-14710961931895 EUDAMEDB-14711182608085 EUDAMEDB-04710961931713 EUDAMED471096193020101F2 EUDAMEDB-14711182608092 EUDAMEDB-14710961932175 EUDAMEDB-14710961931703 EUDAMEDB-14710961931871 EUDAMEDB-14710961936562 EUDAMEDB-14711182608078 EUDAMEDB-04711182628574 EUDAMEDB-04710961931874 EUDAMEDB-04711182607050 EUDAMEDB-14710961931888 EUDAMED
- Direct Marketing DI
- 04711182607050 EUDAMED04710961931713 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
- Italy EUDAMEDBelgium EUDAMEDFrance EUDAMEDFinland EUDAMEDNetherlands EUDAMEDSpain EUDAMEDDenmark 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 — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04711182628550 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04711182628550 | 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 (22)
- EUDAMED a170fe91-c420-4509-b9c4-5ff5a00bfec9 61 fields · synced Sep 30, 2026
- EUDAMED cbc14e06-821b-4db4-a3e4-46a628cc80ef 61 fields · synced May 16, 2026
- EUDAMED 0a72475e-81e0-4991-9b47-55a1cae304d6 61 fields · synced May 17, 2026
- EUDAMED 94df27aa-fdf1-4559-aea3-e088c29b0711 61 fields · synced May 17, 2026
- EUDAMED 03cba645-4d38-446e-88f5-85bfedbd0951 61 fields · synced May 17, 2026
- EUDAMED 1ea44377-5e82-4399-9c3c-b77da243ec35 61 fields · synced May 17, 2026
- EUDAMED eb51ea0c-b319-44f7-9062-9e3f74591009 61 fields · synced May 18, 2026
- FDA UDI 04f75e1e-7728-4d81-8621-7f96899533f9 33 fields · synced May 30, 2026
- FDA UDI b9b8d916-ecea-4b2b-935d-da9fe2ebeaa6 33 fields · synced May 30, 2026
- FDA UDI 4f567a94-67f9-452c-b409-ea6b979a3646 33 fields · synced May 30, 2026
- FDA UDI b286ccd9-aa53-46ac-8124-a3ab6477172a 33 fields · synced May 30, 2026
- FDA UDI 5aa466b9-1350-403f-8392-a844903d79c8 33 fields · synced May 30, 2026
- EUDAMED e6ac7b3b-ddc4-41b6-8996-a87a384c3a6b 61 fields · synced Jul 9, 2026
- EUDAMED deb19514-06c2-4a88-b0e0-d13a404ca879 61 fields · synced Jul 11, 2026
- EUDAMED 2a9523c3-be51-4359-9c8d-f3ef928d7c20 61 fields · synced Jul 13, 2026
- EUDAMED adaf317b-1432-4c01-ad2b-228f4e1dc6bb 61 fields · synced Jul 15, 2026
- EUDAMED a02b5ed7-189d-4bd4-b8c0-5ed2874cea7c 61 fields · synced Jul 16, 2026
- EUDAMED 6c9072aa-ea03-4139-84cd-1155992e358a 61 fields · synced Jul 24, 2026
- EUDAMED a1b0e21e-3e19-4bfc-b108-4c53d765fedd 61 fields · synced Jul 24, 2026
- EUDAMED a67b9256-e323-4aba-a4e0-b931c2068b5b 61 fields · synced Jul 27, 2026
- EUDAMED 31d3f1ee-f34d-4e91-b603-cb49b91ff12d 61 fields · synced Jul 29, 2026
- EUDAMED c462ab71-ecea-4a79-a11c-27befbe0ebd2 61 fields · synced Sep 30, 2026