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sterile Lancet for Single Use

by Shandong Lianfa Medical Plastic Products Co., Ltd.

Ref LF-CE-03-02

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

FDA recalls

1 ongoing

This device is named in the recall

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
United StatesGUDID listing GUDID Number06949517006546 UDI-DI Date19 Mar 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06949517006546 Basic UDI-DI 06949517006546UDI-DIDate26 Dec 2023RegisteredStatusWithdrawn No longer placed on the EU market

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-0226-2026 FDA Class III initiated 25 Jul 2025

    Due to incorrect/lack of Unique Device Identifier (UDI) codes.

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Linkfar
Generic Name
Blood lancet, single-use
Device Name
sterile Lancet for Single Use
Model / Reference
LF-CE-03-02 EUDAMED
LF-TL-28 GUDID
Primary DI / UDI-DI
06949517006546
Basic UDI-DI
B-06949517006546
510(k) Number
FDA Product Code
QRL
EMDN Code
V010402 Lancets without safety systems, single-use
GMDN Term
Blood lancet, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4850
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
LF-CE-03-02
GUDID
LF-TL-28
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
CN-MF-000028790
Authorised representative
Linkfar Healthcare GmbH DE-AR-000005107

Other devices from Shandong Lianfa Medical Plastic Products Co., Ltd.

See all devices from Shandong Lianfa Medical Plastic Products Co., Ltd. →

Properties

  • Sterile YesEUDAMEDNoGUDID
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No