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Single Use Injector NM-401L-0423

by Olympus Medical Systems Corporation

Ref N5417430

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

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170382338 Basic UDI-DI 04953170382338UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170382338 UDI-DI Date21 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
Single Use Injector NM-401L-0423 EUDAMED
Single Use Injector GUDID
Generic Name
General-purpose endoscopic needle, single-use
Device Name
Single-Use Injector_Digestive Endoscopy, Needles
Model / Reference
N5417430 EUDAMED
NM-401L-0423 GUDID
Primary DI / UDI-DI
04953170382338
Basic UDI-DI
B-04953170382338
FDA Product Code
FBK
EMDN Code
G03020101 Digestive endoscopy, single-lumen needles
GMDN Term
General-purpose endoscopic needle, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5417430
GUDID
NM-401L-0423
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

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