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 Male 16" Length FDA UDI
- Model / Reference
- AS861608 EUDAMED1 FDA UDI
- Description
- AMSure® PVC Intermittent Catheter Male 16" Length FDA UDI
Identifiers
- Catalog Number
- AS861608 FDA UDI
- Primary DI / UDI-DI
- 10704411003717 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10704411003717 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
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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 9922f559-b2e4-4dd3-9aa5-344f0642e13a 34 fields · synced Oct 7, 2026
- EUDAMED 77eb361a-8102-4d82-b1e7-4a6a56820c92 61 fields · synced Oct 6, 2026