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Disposable Biopsy Forceps

by Yangzhou Fartley Medical Instrument Technology Co., Ltd. 3 variants

Ref 400112003Model 40010001

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 Number06970900853126 UDI-DI Date19 Oct 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69709008510137W Basic UDI-DI 06970900853126UDI-DIDate22 Feb 2022RegisteredStatusActive

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  • Withdrawn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
Flexible endoscopic biopsy forceps, single-use
Model / Reference
40010001 EUDAMED
400112003 EUDAMED
FTL-BF-23-230-W-O-A GUDID
Primary DI / UDI-DI
06970900853126
Basic UDI-DI
69709008510137W
Direct Marketing DI
06970900853126
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
40010001
400112003
GUDID
FTL-BF-23-230-W-O-A
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000009371
Authorised representative
Prolinx GmbH DE-AR-000005129

Related devices

Category: Flexible endoscopic biopsy forceps, single-use

Other devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd

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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