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Device Explorer · FDA GUDID · GMDN 61579

Blood lancet, single-use

A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

US‑registered devices908in commercial distribution
Companies66labelers on GUDID
Single‑use99%of device records
Sterile93%labelled sterile
Prescription3%Rx‑only share
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Share of device records

Shandong Lianfa Medical Plastic Products Co.,Ltd37041%
Htl Strefa S A11713%
Sterilance Medical (Suzhou) Inc.404%
Promisemed Medical Devices Inc.344%
Mckesson Medical-Surgical Inc.303%
Ningbo Medsun Medical Co., Ltd.202%
Cardinal Health 200, Llc202%
Medline Industries, Inc.202%

Top labelers

CompanyDevicesShare
Shandong Lianfa Medical Plastic Products Co.,Ltd37041%
Htl Strefa S A11713%
Sterilance Medical (Suzhou) Inc.404%
Promisemed Medical Devices Inc.344%
Mckesson Medical-Surgical Inc.303%
Ningbo Medsun Medical Co., Ltd.202%
Cardinal Health 200, Llc202%
Medline Industries, Inc.202%
Shenzhen Yuwen E-Commerce Co., Ltd.182%
Gri Medical & Electronic Technology Co., Ltd.131%
Wal-Mart Stores, Inc.121%
Abound Diagnostics, Inc.121%

Company = labeler of record on GUDID. 66 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AUVONmedisanaOne +StepTwist Lancet(30G)LinkfarTysonBioplusmedTwist Lancet (30G)Safety Lancet PAII(28G)Twist Lancet (28G)Twist LancetSafety Lancet PAII (25G)Safety Lancet PAII (23G)Safety lancet PAII(23G)Safety Lancet PAII (21G)Pull-top Lancet (33G)

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

FDA product codes

CodeNameDevices
FMKLancet, Blood518
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury 184
QRLMultiple Use Blood Lancet For Single Patient Use Only122
QRKSingle Use Only Blood Lancet Without An Integral Sharps Inju115
FMKLancet, blood34
FMKSingle use only blood lancet with an integral sharps injury 27

GMDN & GCC registration

  • GMDN code 61579 · non‑implantable
  • Single‑use 99% · sterile 93% · Rx‑only 3% · OTC 68%
  • 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) · 66Length (Millimeter) · 61Depth (Millimeter) · 31

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

How many blood lancet, single-use products are registered in the US?

908 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Blood lancet, single-use", from 66 companies. The largest labeler is Shandong Lianfa Medical Plastic Products Co.,Ltd with 41% of records.

Which FDA product codes apply?

FMK (Lancet, Blood), FMK (Single Use Only Blood Lancet With An Integral Sharps Injury ), QRL (Multiple Use Blood Lancet For Single Patient Use Only), QRK (Single Use Only Blood Lancet Without An Integral Sharps Inju)

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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