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EndoClot EPAC-1T

by EndoClot Plus Co., Ltd.

Ref EPAC-1T

EndoClot EPAC-1T is a Class I device made by EndoClot Plus Co., Ltd., registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-16972011720516) and listed in FDA GUDID since 18 Mar 2022 (UDI-DI 16972011720516), active as of 12 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-16972011720516 Basic UDI-DI 16972011720516UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number16972011720516 UDI-DI Date18 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-16972011720516 registered 24 Jun 2026 Active
  • FDA GUDID UDI-DI 16972011720516 listed 18 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 16972011720516
  2. Registered EUDAMED B-16972011720516

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EndoClot® EUDAMED
EndoClot GUDID
Generic name
Endoscopic insufflation tubing set, reusable
Model / reference
EPAC-1T
Primary DI / UDI-DI
16972011720516
Basic UDI-DI
B-16972011720516
FDA product code
BYX
EMDN code
Z120499 General medicine instruments - other
GMDN term
Endoscopic insufflation tubing set, reusable
Device class
Class I
Regulation number
868.5860
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic insufflation tubing set, reusable

Similar devices in this category

Other devices filed under GENERAL MEDICINE INSTRUMENTS - OTHER.

Other devices from EndoClot Plus Co., Ltd.

See all devices from EndoClot Plus Co., Ltd. →

Properties

  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)