← Back to catalogue

AMSure® PVC Intermittent Catheter

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AS860616

by Amsino International, Inc.

Identity

Trade Name
AMSure® PVC Intermittent Catheter EUDAMEDFDA UDI
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, reusable FDA UDI
Device Name
Urethral Catheter EUDAMED
AMSure® PVC Intermittent Catheter Female 6" Length FDA UDI
Model / Reference
AS860616 EUDAMED
1 FDA UDI
Description
AMSure® PVC Intermittent Catheter Female 6" Length FDA UDI

Identifiers

Catalog Number
AS860616 FDA UDI
Primary DI / UDI-DI
10704411003656 EUDAMEDFDA UDI
Basic UDI-DI
B-10704411003656 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 EUDAMED
Class 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® PVC Intermittent Catheter by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Amsino International, Inc.

Sources (2)

  • FDA UDI f39f5252-9321-405b-a83f-ed1e21fc9310 34 fields · synced Oct 7, 2026
  • EUDAMED d180e522-2d6d-452c-9026-708daa0416a6 61 fields · synced Jul 9, 2026