Skip to content

Injection needle

by Yangzhou Fartley Medical Instrument Technology Co., Ltd. 7 variants

Ref IHN-23-22-5-230

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06936603212202 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69709008510217V Basic UDI-DI 06936603212202UDI-DIDate10 Mar 2026RegisteredStatusActive

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 found in the data synced 2 Nov 2026.

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  • Withdrawn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
Injection needle EUDAMED
ECO Inject GUDID
Generic Name
Flexible endoscopic biopsy handpiece/needle
Device Name
Disposable Endoscope Injection Needles
Model / Ref / Catalog
IHN-23-22-5-230, FTL-IN-24-230-22-5
Primary DI / UDI-DI
06936603212202
Basic UDI-DI
69709008510217V
Direct Marketing DI
06936603212202
510(k) Number
FDA Product Code
FBK
EMDN Code
G03020101 Digestive endoscopy, single-lumen needles
GMDN Term
Flexible endoscopic biopsy handpiece/needle
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.1500
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
IHN-23-22-5-230
GUDID
FTL-IN-24-230-22-5
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

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

Other properties (19)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No