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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 4 of 6
DeviceModel / ReferenceRegistriesClassStatus
Pentips AN 3495
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB4
FDA UDI
Class IIActive
Unfine Pentips RapidFlow AN 0555SB2
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB2
FDA UDI
Class IIActive
Spartan Nash 1st Tier Unifine Pentips Plus AN 3840NF
FDA UDI
Class IIActive
AutoSqueeze OP 6100
FDA UDI
Class IActive
Unifine Ultra AN 4130
FDA UDI
Class IIActive
Kinray 1st Tier Unifine Pentips Plus AN 3840KI
FDA UDI
Class IIActive
Unistik VacuFlip BC 7101
FDA UDI
Class IIActive
Unistik ShieldLock WS 7112
FDA UDI
Class IIActive
1st Tier Hartig Drug Unifine Pentips AN 3530HAR
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB6
FDA UDI
Class IIActive
Unistik ShieldLock WS 7517
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0860SB9
FDA UDI
Class IIActive
Unifine Pentips AN 2040
FDA UDI
Class IIActive
Unifine Pentips - 4mm x 32G AN 3540
FDA UDI
Class IIActive
Unifine Pentips Plus AN 3840
FDA UDI
Class IIActive
AutoSqueeze OP 6150
FDA UDI
Class IActive
Unifine Pentips Plus AN 0860SB10
FDA UDI
Class IIActive
Rapport SM 2206
FDA UDI
Class IIActive
Unistik 3 AT 1028
FDA UDI
Class IIActive
Unifine Pentips AN 0550SB10
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0829SB6
FDA UDI
Class IIActive
Amielle Restore SM 3100
FDA UDI
Class IActive
Unifine Pentips Plus AN 0890SB2
FDA UDI
Class IIActive
Diabetic Outlet - Unifine Pentips Plus AN 3840DO
FDA UDI
Class IIActive
Unistik VacuFlip BC 7125
FDA UDI
Class IIActive
Unifine Pentips AN 0540SB9
FDA UDI
Class IIActive
Unifine OTC AN 3650
FDA UDI
Class IIActive
Rapport SM 2209
FDA UDI
Class IIActive
Pentips 1st Tier AN 3429FT
FDA UDI
Class IIActive
Pentips 1st Tier AN 3440FT
FDA UDI
Class IIActive
1st Tier Unilet AT 0575FT
FDA UDI
Class IIActive
Unifine Pentips AN 1140
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0840SB5
FDA UDI
Class IIActive
Unilet ComforTouch AT 0465
FDA UDI
Class IIActive
Rapport SM 2205
FDA UDI
Class IIActive
Amielle SM 2103
FDA UDI
Class IIActive
Unifine Pentips Plus AN 3890
FDA UDI
Class IIActive
Unifine Pentips AN 0530SB4
FDA UDI
Class IIActive
Unifine Pentips Plus AN 0850SB3
FDA UDI
Class IIActive
Unistik TinyTouch AT 1250
FDA UDI
Class IIActive
South Pointe Wholesale - Unifine Pentips AN 3550SPW
FDA UDI
Class IIActive
Kinray 1st Tier Unifine Pentips Plus AN 3850KI
FDA UDI
Class IIActive
Unifine Pentips AN 3530
FDA UDI
Class IIActive
Unifine Pentips AN 3529
FDA UDI
Class IIActive
Unifine Pentips AN 0529SB4
FDA UDI
Class IIActive
1st Tier Unilet AT 0585FT
FDA UDI
Class IIActive
Petfine Autoject 2 AJ 3310VET
FDA UDI
Class IIActive
Unifine OTC AN 3641
FDA UDI
Class IIActive

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