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Single-Use ErgoGrip Knob Extender

by Yangzhou Fartley Medical Instrument Technology Co., Ltd. 2 variants

Ref MAJ-2219

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, self-declared

Class I: no certifier involved

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
European UnionCE/MDR EUDAMED Number69709008510478F Basic UDI-DI 06936603228937UDI-DIDate23 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936603228937 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Single-Use ErgoGrip Knob Extender EUDAMED
Single Use Angulation Knob Extender GUDID
Generic Name
Surgical instrument handle grip
Model / Ref / Catalog
MAJ-2219, FTL-DEK-A
Primary DI / UDI-DI
06936603228937
Basic UDI-DI
69709008510478F
Direct Marketing DI
06936603228937
FDA Product Code
MNL
EMDN Code
Z12029085 Various instruments for endoscopy and mini-invasive surgery - consumables
GMDN Term
Surgical instrument handle grip
Device Class
Class I
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MAJ-2219
GUDID
FTL-DEK-A

Manufacturer details

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

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

See all devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: 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
  • Serial Number: No
  • Manufacturing Date: No