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Na AG-5104-2300-090-16

by Hangzhou AGS MedTech Co., Ltd.

Ref AG-5077-241518Model For the "hot" indicated model

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number695966495072000015S Basic UDI-DI 06959664911747UDI-DIDate18 Aug 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06959664911747 UDI-DI Date28 May 2018ListedStatusListed GUDID: not 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Gastrointestinal endoscopic clip, short-term
Device Name
Polypectomy Snare
Model / Ref / Catalog
For the "hot" indicated model EUDAMED
AG-5077-241518 EUDAMED
AG-5104-2300-090-16 GUDID
AG6.510E.4493.000.Z GUDID
Primary DI / UDI-DI
06959664911747
Basic UDI-DI
695966495072000015S
FDA Product Code
PKL
EMDN Code
G03030199 Polypectomy snares - other
GMDN Term
Gastrointestinal endoscopic clip, short-term
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4400
EU market of registration
France
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
For the "hot" indicated model
AG-5077-241518
GUDID
AG-5104-2300-090-16
Device ClassEUDAMED
Class IIb
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Related devices

Category: Gastrointestinal endoscopic clip, short-term

Cleared under the same submission (K172727)

Show all (12)

Similar devices

Also classified as Gastrointestinal endoscopic clip, short-term.

Other devices from Hangzhou AGS MedTech Co., Ltd.

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Properties

  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: 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