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Blood Lancets

by Shandong Lianfa Medical Plastic Products Co., Ltd.

Ref Ⅱ-30GModel Ⅰ Ⅱ Ⅲ

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694951700V8 Basic UDI-DI 06949517006447UDI-DIDate5 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number06949517006447 UDI-DI Date16 Jul 2023ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TysonBio
Generic Name
Blood lancet, single-use
Device Name
Blood Lancets
Model / Reference
Ⅰ Ⅱ Ⅲ EUDAMED
Ⅱ-30G EUDAMED
LF-TL-30 GUDID
Primary DI / UDI-DI
06949517006447
Basic UDI-DI
694951700V8
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Ⅰ Ⅱ Ⅲ
Ⅱ-30G
GUDID
LF-TL-30
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
  • Manufacturing Date

Other properties (20)

  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No