AMSure® PVC Intermittent Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AMSure® PVC Intermittent Catheter EUDAMEDFDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
- Device Name
- Urethral Catheter EUDAMEDAMSure® PVC Intermittent Catheter Female 6" Length FDA UDI
- Model / Reference
- AS860606 EUDAMED1 FDA UDI
- Description
- AMSure® PVC Intermittent Catheter Female 6" Length FDA UDI
Identifiers
- Catalog Number
- AS860606 FDA UDI
- Primary DI / UDI-DI
- 10704411003601 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411003601 EUDAMED
- FDA Product Code
- EZD FDA UDI
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, reusable 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
No
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: Intermittent urethral drainage catheter, non-antimicrobial, reusable
AMSure® PVC Intermittent Catheter by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, reusable.
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinal Health 200, LLC · Class II
- Dover — Cardinalhealth · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (2)
- FDA UDI e560febe-59a5-4519-be62-61c922b86157 34 fields · synced Oct 6, 2026
- EUDAMED 01cd3bdd-c5dd-4ea1-98e1-d4b1c9f0a470 61 fields · synced Oct 5, 2026