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Unistik 3 Sterile Single-Use Safety Lancets

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221126Ref AT1563CA000Model UX-0563-00-00*

by Owen Mumford Ltd

Identity

Trade Name
Abbott SF EUDAMED
Device Name
Abbott SF EUDAMED
Model / Reference
UX-0563-00-00* EUDAMED
AT1563CA000 EUDAMED

Identifiers

Primary DI / UDI-DI
05021791709014 EUDAMED
Basic UDI-DI
5016189ABBOTTSFTG EUDAMED
510(k) Number
K221126 FDA 510(k)
FDA Product Code
FMK FDA 510(k)
EMDN Code
V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Models / Variants
Unistik® 3, sterile single-use safety lancets FDA 510(k)EUDAMED
Unistik® 3 Value, sterile single-use safety lancets FDA 510(k)EUDAMED
Abbott SF sterile single-use safety lancets FDA 510(k)EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4850 FDA 510(k)
Regulation Number
878.4850 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

The Unistik 3 Sterile Single-Use Safety Lancets are classified as safety lancets designed for blood sampling and glucose monitoring. These devices feature a retractable needle mechanism to minimise post-procedure exposure risk, ensuring safe and hygienic use in clinical and home settings. Their ergonomic design facilitates precise skin penetration while reducing discomfort for the user.

Supplied sterile and intended for single-use, these lancets are intended for use in both medical and self-monitoring environments. They comply with FDA 510(k) clearance and MDR requirements, ensuring regulatory adherence. Available in various sizes, they are packaged individually for convenience and must be stored in a clean, dry environment to maintain sterility. No MRI safety information is specified.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Owen Mumford Ltd
FDA Applicant
Owen Mumford, Ltd.

Sources (2)

  • FDA 510(k) K221126 24 fields · synced Oct 6, 2026
  • EUDAMED 7f8fc63f-29f5-473d-873b-2738d512e253 61 fields · synced Jul 19, 2026