Identity
- Trade Name
- SoftSimplastic 2 Way Foley Couvelaire Tip Catheter EUDAMEDRUSCH FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- SOFTSIMPLASTIC 2W 30ML COUVELAIRE C EUDAMEDSoftSimplastic 2 Way Foley Couvelaire Tip Catheter FDA UDI
- Model / Reference
- 662530-000160 EUDAMEDIPN052898 FDA UDI
- Description
- SoftSimplastic 2 Way Foley Couvelaire Tip Catheter FDA UDI
Identifiers
- Catalog Number
- 662530-000160 FDA UDI
- Primary DI / UDI-DI
- 04026704069699 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04026704069699 EUDAMED
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- U010202 URETHRAL PROSTATIC AND BLADDER CATHETERS, COUVELAIRE, WITH BALLOON EUDAMED
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
Yes
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 5.3 Millimeter FDA UDI
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Rusch by Teleflex Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
- BIP Foley Catheter 2-way, 18 Ch/Fr, 30ml/cc — Bactiguard AB · Class IIb
- All Silicone Foley Catheter — Well Lead Medical Co., Ltd · Class II
- Foley Catheter — GERI-GENTLE CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI fcb723cd-87bf-4dc7-b6c1-ab9445c25dc1 36 fields · synced Oct 10, 2026
- EUDAMED 3d050bd7-a0a5-4d2f-859a-890ff39bd878 61 fields · synced Oct 9, 2026