Autolet

FDA UDI

Class II (US FDA UDI)

by Owen Mumford Usa Incorporated

Identity

Trade Name: Autolet FDA UDI
Generic Name: Manual blood lancing device, reusable FDA UDI
Device Name: Autolet Lancing Device with 10 30G lancets in a bag FDA UDI
Model / Reference: AT 0272 FDA UDI
Description: Autolet Lancing Device with 10 30G lancets in a bag FDA UDI

Identifiers

Primary DI / UDI-DI: 00384700272012 FDA UDI
FDA Product Code: QRL FDA UDI
GMDN Term: Manual blood lancing device, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Manual blood lancing device, reusable

Autolet by Owen Mumford Usa Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual blood lancing device, reusable.

Pylo Health — PREVOUNCE HEALTH, INC · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
BEWELL CONNECT MyGluco Lancing device — Visiomed Group SA · Class II
Lancing Device — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
TeleRPM & Chronica — Mio Labs Inc.
Accu-Chek Safe-T-Pro — ROCHE DIABETES CARE, INC. · Class II
Accu-Chek Fastclix — ROCHE DIABETES CARE, INC. · Class II
Medtlet — Carelife (usa) Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Owen Mumford Usa Incorporated

Sources (1)

FDA UDI f8f2e0d2-1022-4796-b3a5-ea055d28e114 33 fields · synced Jun 1, 2026