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AMSure® 100% Silicone Foley Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS42020S
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
- AS42020S EUDAMED1 FDA UDI
- Description
- AMSure® 100% Silicone Foley Catheter Radiopaque FDA UDI
Identifiers
- Catalog Number
- AS42020S FDA UDI
- Primary DI / UDI-DI
- 10704411002055 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411002055 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
AMSure® 100% Silicone Foley Catheter by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 4185b932-2dc1-4144-94ad-70c54f5b410a 35 fields · synced Oct 6, 2026
- EUDAMED 1905e480-a04e-4639-a4c1-23ae8f942c9d 61 fields · synced Jul 17, 2026