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OWEN MUMFORD USA INCORPORATED

US

Last updated May 24, 2026

What OWEN MUMFORD USA INCORPORATED makes

The company manufactures single-use and reusable blood lancing devices, including manual lancets and needle tips designed for skin puncture, as well as autoinjector needles for drug delivery. It also produces blood collection sets for invasive procedures, penile vacuum devices for erectile dysfunction treatment, and vaginal dilators for medical or therapeutic use. Additional products include reusable manual blood lancing devices and aids for eye dropper bottles to assist with medication administration.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to applicable U.S. medical device compliance requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
770-977-2226
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
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DUNS Number
803401454

Catalogue (296)

Page 3 of 6
DeviceModel / ReferenceRegistriesClassStatus
Unifine Pentips AN 0550SB5
FDA UDI
Class IIActive
Unifine Pentips Plus AN0840SB7
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0850SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0830SB4
FDA UDI
Class IIActive
Unifine Pentips AN 0590SB3
FDA UDI
Class IIActive
Unifine Pentips AN 0560SB9
FDA UDI
Class IIActive
Diabetic Outlet - Pentips AN 3450DO
FDA UDI
Class IIActive
Unifine Pentips Plus 1st Tier AN 3840FT
FDA UDI
Class IIActive
Pentips 1st Tier AN 3430FT
FDA UDI
Class IIActive
Unilet AT 0565
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB2
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0840SB6
FDA UDI
Class IIActive
Unifine Safe Control AN 0955SB2
FDA UDI
Class IIActive
TopRx 1st Tier Pentips AN 3450TRX
FDA UDI
Class IIActive
Diabetic Outlet - Pentips AN 3490DO
FDA UDI
Class IIActive
Unistik VacuFlip BC 7252
FDA UDI
Class IIActive
Unifine Pentips Plus AN 1850
FDA UDI
Class IIActive
Unifine Pentips AN 2029
FDA UDI
Class IIActive
Unifine Pentips Plus AN 3850
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0829SB3
FDA UDI
Class IIActive
Unifine Pentips AN 0590SB4
FDA UDI
Class IIActive
Unifine Pentips AN 0540SB3
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB5
FDA UDI
Class IIActive
Unistik TinyTouch AT 1210
FDA UDI
Class IIActive
1st Tier Unifine Pentips Plus AN 3830FT
FDA UDI
Class IIActive
Unifine Pentips AN 3595
FDA UDI
Class IIActive
Unifine Pentips AN 0550SB6
FDA UDI
Class IIActive
Unifine Ultra AN 4150
FDA UDI
Class IIActive
Unifine Pentips AN 0560SB10
FDA UDI
Class IIActive
Pentips AN 3450
FDA UDI
Class IIActive
Unifine Pentips AN 0560SB4
FDA UDI
Class IIActive
Unifine Pentips Plus AN 2829
FDA UDI
Class IIActive
Unifine Pentips AN 0590SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB5
FDA UDI
Class IIActive
Unilet AT 0585
FDA UDI
Class IIActive
TopRx 1st Tier Pentips AN 3430TRX
FDA UDI
Class IIActive
Unilet AT 0575
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0890SB9
FDA UDI
Class IIActive
Amielle SM 2104
FDA UDI
Class IIActive
Pentips AN 3490
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0850SB4
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0840SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN 1830
FDA UDI
Class IIActive
1st Tier Hartig Drug Unifine Pentips AN 3529HAR
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB8
FDA UDI
Class IIActive
1st Tier Hartig Drug Unifine Pentips AN 3540HAR
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB9
FDA UDI
Class IIActive
Autolet AT 0270
FDA UDI
Class IIActive

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