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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 2 of 6
DeviceModel / ReferenceRegistriesClassStatus
Amielle SM 2102
FDA UDI
Class IIActive
Diabetic Outlet - Pentips AN 3440DO
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB6
FDA UDI
Class IIActive
Unistik VacuFlip BC 7226
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB7
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0890SB3
FDA UDI
Class IIActive
Unistik VacuFlip BC 7102
FDA UDI
Class IIActive
Unifine Pentips AN 3590
FDA UDI
Class IIActive
Kinray 1st Tier Unifine Pentips Plus AN 3890KI
FDA UDI
Class IIActive
Unistik TinyTouch AT 1267
FDA UDI
Class IIActive
Unifine OTC AN 3651
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0850SB5
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0830SB9
FDA UDI
Class IIActive
Unistik VacuFlip BC 7251
FDA UDI
Class IIActive
Unifine Pentips AN 0550SB9
FDA UDI
Class IIActive
Unilet ComforTouch AT 0455
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB2
FDA UDI
Class IIActive
TopRx 1st Tier UP AN 3595TRX
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0840SB9
FDA UDI
Class IIActive
Unifine Pentips AN 3529AC
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0890SB7
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB10
FDA UDI
Class IIActive
Unifine SafeControl AN 7935
FDA UDI
Class IIActive
Unifine Pentips AN 3550
FDA UDI
Class IIActive
Diabetic Outlet - Unifine Pentips Plus AN 3890DO
FDA UDI
Class IIActive
Unfine SafeControl AN 7940
FDA UDI
Class IIActive
Unifine Pentips Plus AN 2850
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB10
FDA UDI
Class IIActive
Unistik VacuFlip BC 7025
FDA UDI
Class IIActive
Unifine Pentips AN 3440
FDA UDI
Class IIActive
Unistik ShieldLock WS 7117
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0829SB4
FDA UDI
Class IIActive
Unifine Pentips AN 0540SB2
FDA UDI
Class IIActive
1st Tier Unifine Pentips Plus AN 3850FT
FDA UDI
Class IIActive
Unifine Pentips Plus RapidFlow AN 0855SB2
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0830SB5
FDA UDI
Class IIActive
1st Tier Unifine Pentips Mini AN 3550FT
FDA UDI
Class IIActive
Unifine Pentips Plus AN 3829
FDA UDI
Class IIActive
Premier Value 1st Tier Unifine Pentips Plus AN 0860CDCSB2
FDA UDI
Class IIActive
Unistik TinyTouch AT 1200
FDA UDI
Class IIActive
Unifine Pentips Plus AN 1840
FDA UDI
Class IIActive
Autolet AT 0271
FDA UDI
Class IIActive
TopRx 1st Tier UP AN 3429TRX
FDA UDI
Class IIActive
Unistik ShieldLock WS 7322
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0890SB8
FDA UDI
Class IIActive
Unifine Pentips Plus AN0829SB10
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0840SB3
FDA UDI
Class IIActive
1st Tier Unifine Pentips Plus Original AN 3829FT
FDA UDI
Class IIActive
Unistik VacuFlip BC 7026
FDA UDI
Class IIActive
1st Tier Unifine Pentips Short AN 3530FT
FDA UDI
Class IIActive

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