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AMSure® 100% Silicone Foley Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS41024SRef AS43024SRef AS41018SRef AS43018SRef AS40010SRef AS42026SRef AS42022SRef AS42020SRef AS43020SRef AS43022SRef AS41026SRef AS42014SRef AS41014S
Identity
- Trade Name
- AMSure® 100% Silicone Foley Catheter EUDAMEDFDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Foley Catheter EUDAMEDAMSure® 100% Silicone Foley Catheter Radiopaque FDA UDI
- Model / Reference
- AS41024S EUDAMEDAS43024S EUDAMEDAS41018S EUDAMEDAS43018S EUDAMEDAS40010S EUDAMEDAS42026S EUDAMEDAS42022S EUDAMEDAS42020S EUDAMEDAS43020S EUDAMEDAS43022S EUDAMEDAS41026S EUDAMEDAS42014S EUDAMEDAS41014S EUDAMED1 FDA UDI
- Description
- AMSure® 100% Silicone Foley Catheter Radiopaque FDA UDI
Identifiers
- Catalog Number
- AS43024S FDA UDIAS43018S FDA UDIAS43020S FDA UDIAS41014S FDA UDIAS43022S FDA UDIAS40010S FDA UDIAS41018S FDA UDIAS42026S FDA UDIAS42014S FDA UDIAS41024S FDA UDIAS42020S FDA UDIAS42022S FDA UDIAS41026S FDA UDI
- Primary DI / UDI-DI
- 10704411002154 EUDAMEDFDA UDI10704411002123 EUDAMEDFDA UDI10704411002130 EUDAMEDFDA UDI10704411001928 EUDAMEDFDA UDI10704411002147 EUDAMEDFDA UDI10704411001904 EUDAMEDFDA UDI10704411001942 EUDAMEDFDA UDI10704411002086 EUDAMEDFDA UDI10704411002024 EUDAMEDFDA UDI10704411001973 EUDAMEDFDA UDI10704411002055 EUDAMEDFDA UDI10704411002062 EUDAMEDFDA UDI10704411001980 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411001973 EUDAMEDB-10704411002154 EUDAMEDB-10704411001942 EUDAMEDB-10704411002123 EUDAMEDB-10704411001904 EUDAMEDB-10704411002086 EUDAMEDB-10704411002062 EUDAMEDB-10704411002055 EUDAMEDB-10704411002130 EUDAMEDB-10704411002147 EUDAMEDB-10704411001980 EUDAMEDB-10704411002024 EUDAMEDB-10704411001928 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
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
Yes
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
No
FDA UDI
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
AMSure® 100% Silicone Foley Catheter by Amsino International, Inc. — 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
- 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® 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
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 (26)
- FDA UDI f0eb2be7-1b6b-41bf-b164-041ed669ee15 35 fields · synced Sep 18, 2026
- FDA UDI f42ab1ec-0352-4ae0-8cd6-f025d2fa8d36 35 fields · synced May 29, 2026
- FDA UDI d51eedcc-f22d-4884-b4ff-0c3da9264ed8 35 fields · synced May 30, 2026
- FDA UDI 53fbd7e5-7b89-4ae2-bbf0-a25788800dea 35 fields · synced May 30, 2026
- FDA UDI e78777f4-5315-4544-ac08-6687c5ea38ac 35 fields · synced May 30, 2026
- FDA UDI 55f75fdc-951b-4405-bea9-0489fa7c74d6 35 fields · synced May 30, 2026
- FDA UDI 18a5d2ed-8f3d-48dc-862e-8ddb8f661297 35 fields · synced May 30, 2026
- FDA UDI 3f7040d4-6515-4f73-a7d4-58667a0d4408 35 fields · synced May 30, 2026
- FDA UDI d51e25c7-c41a-48f7-aaa1-15e4ef5711e4 35 fields · synced May 30, 2026
- FDA UDI 216d6132-082c-4af3-83f2-2477a9313985 35 fields · synced May 30, 2026
- FDA UDI 4185b932-2dc1-4144-94ad-70c54f5b410a 35 fields · synced May 30, 2026
- FDA UDI 7ee06664-5f02-44d6-a53e-46ee8cc349e4 35 fields · synced May 30, 2026
- FDA UDI 5349481d-92a9-4361-8420-72dafa5fb9cd 35 fields · synced May 30, 2026
- EUDAMED bb07ff2f-fb55-4065-8509-9e92e9bd639e 61 fields · synced Jul 8, 2026
- EUDAMED 42ff37e6-1b71-4e9f-ba28-151a6420d33a 61 fields · synced Jul 8, 2026
- EUDAMED 18f7143c-dbea-4476-9570-cd01e5266b72 61 fields · synced Jul 9, 2026
- EUDAMED 89bac11b-7cf4-4890-be8f-9329a711f4f2 61 fields · synced Jul 11, 2026
- EUDAMED 689c3da9-039f-4a6a-b3ab-74062553196b 61 fields · synced Jul 12, 2026
- EUDAMED 5ae9bb67-c0f6-4d4a-9ef9-ad06787fa3ec 61 fields · synced Jul 14, 2026
- EUDAMED 683acee1-0993-44cc-a5e3-7e7a54cc4fa6 61 fields · synced Jul 15, 2026
- EUDAMED 1905e480-a04e-4639-a4c1-23ae8f942c9d 61 fields · synced Jul 17, 2026
- EUDAMED 4dd36152-b198-442e-9231-f3a228e562ef 61 fields · synced Jul 18, 2026
- EUDAMED 4d12a3e6-5cc3-453e-b08f-f3c3a07e0c77 61 fields · synced Jul 19, 2026
- EUDAMED ec77f85d-9bfa-4254-84e1-100e1f7caa25 61 fields · synced Jul 24, 2026
- EUDAMED fc1f57be-ad1e-405a-8693-a60897760667 61 fields · synced Jul 29, 2026
- EUDAMED b0968a5a-84c1-4ea9-aebc-8f106df79cdc 61 fields · synced Sep 18, 2026