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AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water 1

by Amsino International, Inc.

Ref CIS3530

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10704411007463 Basic UDI-DI 10704411007463UDI-DIDate9 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411007463 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaNetherlands
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed
  • Netherlands

Specification

EUDAMED · GUDID

Trade Name
AMSure® Pre-Filled Syringe for Balloon Inflation with Sterile Water EUDAMED
AMSure ®Pre-Filled Syringe for Balloon Inflation with Sterile Water GUDID
Generic Name
Catheter/overtube balloon inflator, single-use
Device Name
Pre-filled syringe
Model / Ref / Catalog
CIS3530, 1
Primary DI / UDI-DI
10704411007463 EUDAMED
40704411007464 GUDID
Basic UDI-DI
B-10704411007463
FDA Product Code
EZL
EMDN Code
A02010702 Prefilled syringes with sterile water
GMDN Term
Catheter/overtube balloon inflator, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CIS3530
GUDID
1
Primary DI / UDI-DIEUDAMED
10704411007463
GUDID
40704411007464
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Amsino International, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No