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Device Explorer · FDA GUDID · GMDN 45142

Blood lancing device tip

A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic pati

US‑registered devices159in commercial distribution
Companies35labelers on GUDID
Single‑use94%of device records
Sterile91%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Tianjin Huahong Technology Co., Ltd.3522%
Trividia Health, Inc.2516%
Owen Mumford Usa Incorporated117%
Care Living Diagnostics Inc.85%
Prestige Ameritech, Ltd.64%
Simple Diagnostics Inc53%
I-Sens, Inc.53%
Livongo Health, Inc53%

Top labelers

CompanyDevicesShare
Tianjin Huahong Technology Co., Ltd.3522%
Trividia Health, Inc.2516%
Owen Mumford Usa Incorporated117%
Care Living Diagnostics Inc.85%
Prestige Ameritech, Ltd.64%
Simple Diagnostics Inc53%
I-Sens, Inc.53%
Livongo Health, Inc53%
Asahi Polyslider Company,Limited53%
Teladoc Health, Inc.53%
Fora Care Inc.43%
Fondcircle Inc.43%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Lite TouchTD-THIN Sterile Lancets (100pcs/box)BEWELL CONNECT MyGluco LancetFORAPharmacist ChoiceComfort EZ Safety LancetCareSensOne DropLivongo Refill KitLivongo LancetsFondCircleLIVE TULA LT-THIN Lancets(100PCS/BOX)Dario 100 Sterile LancetsCOMFORT TOUCHGOJJI LANCET 30G-GLUCOSE TEST STRIPGOJJI LANCETS 30G

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
QRKSingle Use Only Blood Lancet Without An Integral Sharps Inju130
QRLMultiple Use Blood Lancet For Single Patient Use Only55
FMKLancet, Blood36
NBWSystem, Test, Blood Glucose, Over The Counter11
LFRGlucose Dehydrogenase, Glucose11
CGAGlucose Oxidase, Glucose8

GMDN & GCC registration

  • GMDN code 45142 · non‑implantable
  • Single‑use 94% · sterile 91% · Rx‑only 3% · OTC 87%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 87Depth (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many blood lancing device tip products are registered in the US?

159 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood lancing device tip", from 35 companies. The largest labeler is Tianjin Huahong Technology Co., Ltd. with 22% of records.

Which FDA product codes apply?

QRK (Single Use Only Blood Lancet Without An Integral Sharps Inju), QRL (Multiple Use Blood Lancet For Single Patient Use Only), FMK (Lancet, Blood), NBW (System, Test, Blood Glucose, Over The Counter)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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