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Silicone 2-way Foley Balloon Catheter Tiemann Tip
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 4856-0222Ref 4856-0216Ref 4856-0218Ref 1856-0214Ref 1856-0218Ref 4856-0220
Identity
- Trade Name
- Silicone 2-way Foley Balloon Catheter Tiemann Tip EUDAMEDSilicone 2-way Foley Catheter Tiemann Tip (Standard Balloon) FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Silicone 2-way Foley Balloon Catheter Tiemann Tip EUDAMED
- Model / Reference
- 4856-0222 EUDAMED4856-0216 EUDAMED4856-0218 EUDAMED1856-0214 EUDAMED1856-0218 EUDAMEDFDA UDI4856-0220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14710961937132 EUDAMED14710961937101 EUDAMED14710961937118 EUDAMED14710961933356 EUDAMED04710961933373 EUDAMEDFDA UDI14710961937125 EUDAMED
- Basic UDI-DI
- B-14710961937132 EUDAMEDB-14710961937101 EUDAMEDB-14710961937118 EUDAMEDB-14710961933356 EUDAMEDB-04710961933373 EUDAMEDB-14710961937125 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 EUDAMEDDenmark EUDAMEDItaly 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone 2-way Foley Balloon Catheter Tiemann Tip 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-14710961937132 | 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 (7)
- EUDAMED c68baa97-8c2f-4a6e-8897-01dfb2bfa84c 61 fields · synced Sep 18, 2026
- EUDAMED 21cac8fa-eeb6-4861-be05-acdf523a7ba8 61 fields · synced May 17, 2026
- EUDAMED 76e6355f-236c-411a-9a39-c3a918b60faa 61 fields · synced May 17, 2026
- EUDAMED c1b7d0d4-964e-41c0-b2bf-08d28186aaf6 61 fields · synced May 19, 2026
- EUDAMED 2905b267-07b2-4b50-a71a-6345f059474d 61 fields · synced May 19, 2026
- EUDAMED d5059530-ab42-44ab-b4a3-18161879fe21 61 fields · synced May 19, 2026
- FDA UDI 8a4e2e58-b4fc-4347-8173-a9d83c7a058c 33 fields · synced May 30, 2026