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Lake Region Medical

US

Last updated September 17, 2026

About

We provide innovative, high quality medical device technologies - including catheters, guidewires, introducers, delivery systems, tantalum capacitors, implantable ports, neuromodulation devices, pacemaker batteries, implantable and external batteries, and much more – to meet customers’ needs and help enhance the lives of patients worldwide. The products we design and manufacture range from finished device systems to Class III Medical Devices and hundreds of components dispersed among more than 15 markets. We also provide market-ready products to medical device OEMs. From product design to completed systems, our expertise in medical device development and battery design is foundational to the history of cardiac rhythm and cardio and vascular health.

From the manufacturer's own website. Source

Information

Country
US
Address
340 Lake Hazeltine Dr, CHASKA, MN, 55318
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2126666
DUNS Number
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Catalogue (235)

Page 1 of 5
DeviceModel / ReferenceRegistriesClassStatus
Forté™ H74934949050
FDA UDI
Class IIActive
M-Wire Hydrophilic Coated LR1BG027
FDA UDI
Class IIActive
Starter™ Guidewire M001491751
FDA UDI
Class IIActive
Paragon LR1BF022V
FDA UDI
Class IIActive
Starter™ Guidewire M001491451
FDA UDI
Class IIActive
ZIPwire™ M00146322B0
FDA UDI
Class IIActive
Forté™ H7493494901J0
FDA UDI
Class IIActive
Thruway™ M001492771
FDA UDI
Class IIActive
ZIPwire™ M00146154B0
FDA UDI
Class IIActive
ZIPwire™ M006630222B0
FDA UDI
Class IActive
ZIPwire™ M0066802160
FDA UDI
Class IActive
ZIPwire™ M00146350B0
FDA UDI
Class IIActive
Forté™ H7493494902J0
FDA UDI
Class IIActive
ZIPwire™ M0066802020
FDA UDI
Class IActive
Starter™ Guidewire M001491331
FDA UDI
Class IIActive
Dc-Om-Cca, W, Int 145-018 LR1BG-057
FDA UDI
Class IIActive
Starter™ Guidewire M001492281
FDA UDI
Class IIActive
Starter™ Guidewire M001492301
FDA UDI
Class IIActive
Starter™ Guidewire M001491021
FDA UDI
Class IIActive
Thruway™ M001492751
FDA UDI
Class IIActive
ZIPwire™ M0066802070
FDA UDI
Class IActive
ZIPwire™ M0066802130
FDA UDI
Class IActive
ZIPwire™ M00146159B0
FDA UDI
Class IIActive
Starter™ Guidewire M001492371
FDA UDI
Class IIActive
ZIPwire™ M00146301B0
FDA UDI
Class IIActive
Revita® Guidewire FRABF-002V
FDA UDI
Class IIActive
NaviPro™ M00556210
FDA UDI
Class IIActive
Forté™ H74934949070
FDA UDI
Class IIActive
PTFE Coated Urological Guidewire M0066201030
FDA UDI
Class IActive
ZIPwire™ M00146321B0
FDA UDI
Class IIActive
Safari2™ H74939706JPNXS0
FDA UDI
Class IIUnknown
ZIPwire™ M0066802240
FDA UDI
Class IActive
PTFE Coated Urological Guidewire M0066201300
FDA UDI
Class IActive
M-Wire LR1BG048
FDA UDI
Class IIActive
ZIPwire™ M00146306B0
FDA UDI
Class IIActive
SAFARI2™ Extra Support H74939598ESL0
FDA UDI
Class IIActive
M-Wire LR1BG018
FDA UDI
Class IIActive
Paragon LR1BF031V
FDA UDI
Class IIActive
Paragon LR1BF042V
FDA UDI
Class IIActive
Starter™ Guidewire M001491601
FDA UDI
Class IIActive
ZIPwire™ M00146255B0
FDA UDI
Class IIActive
ZIPwire™ M006630200B0
FDA UDI
Class IActive
ZIPwire™ M00146320B0
FDA UDI
Class IIActive
Thruway™ M001492761
FDA UDI
Class IIActive
Taxi LR1BG035
FDA UDI
Class IIActive
Forté™ H74934949020
FDA UDI
Class IIActive
M-Wire LR1BG052
FDA UDI
Class IIActive
ZIPwire™ M006630205B0
FDA UDI
Class IActive
ZIPwire™ M0066802270
FDA UDI
Class IActive
Starter™ Guidewire M001491831
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Lake Region Medical Limited NEW ROSS Wexford · IE FEI 3002807439