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Hemoclip

by Hangzhou AGS MedTech Co., Ltd. 206 variants

Ref AG-51016-2300-135-13

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

CE MDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06959664904039 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number6959664951010000129 Basic UDI-DI 06959664904039UDI-DIDate11 Apr 2025RegisteredStatusActive

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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Gastrointestinal endoscopic clip, short-term
Device Name
Hemoclip
Model / Reference
AG-51016-2300-135-13
Primary DI / UDI-DI
06959664904039
Basic UDI-DI
6959664951010000129
FDA Product Code
PKL
EMDN Code
G030202 Digestive endoscopy, haemostasis clips
GMDN Term
Gastrointestinal endoscopic clip, short-term
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4400
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000011718
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou AGS MedTech Co., Ltd.

See all devices from Hangzhou AGS MedTech Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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