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NA E8C Reusable Guide Attachment

by GE Healthcare Japan Corporation

Ref H40412LN, 5756502Model 5756502

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00137H8 Basic UDI-DI 00840682125840UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682125840 UDI-DI Date15 Nov 2017ListedStatusListed 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  • Withdrawn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 Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
E8C Reusable Guide Attachment
Generic Name
Needle guide, reusable
Model / Reference
5756502 EUDAMED
H40412LN EUDAMED
E8C Reusable Guide Attachment GUDID
Primary DI / UDI-DI
00840682125840
Basic UDI-DI
8406821BUG00137H8
Direct Marketing DI
00840682125840
FDA Product Code
MJG
EMDN Code
A018002 Needle guides
GMDN Term
Needle guide, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5756502
H40412LN, 5756502
GUDID
E8C Reusable Guide Attachment

Related devices

Category: Needle guide, reusable

Other devices from GE Healthcare Japan Corporation

See all devices from GE Healthcare Japan Corporation →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • 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
  • Lot / Batch Number: No
  • Expiration Date: No