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AMSure ® Hydrophilic Latex Foley Catheters
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS41024H
Identity
- Trade Name
- AMSure® Hydrophilic Latex Foley Catheter EUDAMEDAMSure ® Hydrophilic Latex Foley Catheters FDA UDI
- Generic Name
- Ureteral catheter FDA UDI
- Device Name
- Hydrophilic Foley Catheter EUDAMEDHydrophilic Latex Foley Catheters, 24FR, 5cc. FDA UDI
- Model / Reference
- AS41024H EUDAMED1 FDA UDI
- Description
- Hydrophilic Latex Foley Catheters, 24FR, 5cc. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10704411008996 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411008996 EUDAMED
- 510(k) Number
- K091699 FDA UDI
- FDA Product Code
- EZL FDA UDI
- EMDN Code
- U020201 URETERAL CATHETERS FOR OCCLUSION EUDAMED
- GMDN Term
- Ureteral catheter 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
Yes
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: Ureteral catheter
AMSure ® Hydrophilic Latex Foley Catheters by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ureteral catheter.
- Bard® Polyurethane Ureteral Catheters, Open Tip — C. R. Bard, Inc. · Class II
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Bard® Woven Ureteral Catheter — C. R. Bard, Inc. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Ureteral Catheter — Well Lead Medical Co., Ltd · Class II
- Coloplast — Coloplast A/S · Class II
- UroForce® Balloon Dilation Catheter — C. R. Bard, Inc. · Class II
- Metal Catheter — RZ-Medizintechnik GmbH · Class I
Cleared under the same submission
K091699 also covers:
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- AMSure ® Hydrophilic Latex Foley Catheters — AMSINO INTERNATIONAL, INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI 469e1326-0597-48c1-ae8f-d9bc46b18d72 34 fields · synced Oct 5, 2026
- EUDAMED f5b23feb-8cd1-4444-bd50-76e1788d9a93 61 fields · synced Oct 5, 2026