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AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ Tip 1

by Amsino International, Inc.

Ref ENS115, ENS115NS

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

CE MDR 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-10704411007081 Basic UDI-DI Date5 Jun 2026RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-10704411007081 Basic UDI-DI Date5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10704411006169 UDI-DI Date24 Jun 2025ListedStatusListed 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 AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
AMSure® Enteral Feeding Flat Top Piston Syringe EUDAMED
AMSure® Enteral Feeding Flat Top Piston Syringe with ENFit™ Tip GUDID
Generic Name
ENFit oral/enteral syringe, single-use
Device Name
Enteral feeding syringe
Model / Ref / Catalog
ENS115, ENS115NS, 1
Description
60cc Flat Top Piston Syringe with ENFit Tip Tip Protector
Primary DI / UDI-DI
10704411006169, 10704411007081
Basic UDI-DI
B-10704411007081, 0704411338Z5
FDA Product Code
PNR
EMDN Code
A020108 Enteral feeding syringes
GMDN Term
ENFit oral/enteral syringe, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5980
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ENS115
ENS115NS
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: ENFit oral/enteral syringe, single-use

Other devices from Amsino International, Inc.

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Properties

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

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: 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