AMSure® Silicone Coated Latex Foley Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AMSure® Silicone Coated Latex Foley Catheter EUDAMEDFDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Foley Catheter EUDAMEDAMSure® Silicone Coated Latex Foley Catheter FDA UDI
- Model / Reference
- AS43022 EUDAMED1 FDA UDI
- Description
- AMSure® Silicone Coated Latex Foley Catheter FDA UDI
Identifiers
- Catalog Number
- AS43022 FDA UDI
- Primary DI / UDI-DI
- 10704411001751 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411001751 EUDAMED
- 510(k) Number
- K082815 FDA UDI
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- U020201 URETERAL CATHETERS FOR OCCLUSION 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
Yes
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
AMSure® Silicone Coated Latex Foley Catheter by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
Cleared under the same submission
K082815 also covers:
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® Silicone Coated Latex Foley Catheter — AMSINO INTERNATIONAL, INC.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
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
- Amsino International, Inc.
Sources (2)
- FDA UDI 914eb577-7a45-4789-a68c-41e7b891f19f 35 fields · synced Oct 6, 2026
- EUDAMED 43b3b71f-a0fb-49eb-9ac0-560d9217191c 61 fields · synced Oct 6, 2026