Skip to content

Disposable Biopsy Forceps Fb-214U

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union

Ref N5356130

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170354199 Basic UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170354199 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Disposable Biopsy Forceps Fb-214U EUDAMED
Disposable Biopsy Forceps GUDID
Generic Name
Flexible endoscopic biopsy forceps, single-use
Device Name
Gastrointestinal Endoscopy, Forceps, Single-Use
Model / Ref / Catalog
N5356130, FB-214U
Primary DI / UDI-DI
04953170354199
Basic UDI-DI
B-04953170354199
FDA Product Code
FCL
EMDN Code
G0308010101 Gastrointestinal endoscopy, cold biopsy forceps, single-use
GMDN Term
Flexible endoscopic biopsy forceps, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
876.1075
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5356130
GUDID
FB-214U
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Flexible endoscopic biopsy forceps, single-use

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • 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
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No