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METREX RESEARCH

United States·US-MF-000043710

Last updated September 17, 2026

What METREX RESEARCH makes

Metrex Research manufactures reusable surgical binoculars, including loupes and powered loupes for precision procedures, as well as general-purpose light sources like LED curing lights and headlight systems for surgical illumination. Their portfolio also includes single-use dental polishing cups, non-sterile instrument drapes, and protective covers for cables, leads, sensors, and probes. Additionally, they produce cleaning and disinfection wipes, disinfection agents, and decontamination agents for medical device reprocessing.

The company’s devices are classified under EU Medical Device Regulations as Class I and Class II, with corresponding FDA UDI listings. Their products are registered in the EU’s eudamed database and the FDA’s UDI system, reflecting compliance with regulatory requirements for both reusable and single-use medical instruments. The manufacturer is based in the United States.

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

Information

Country
United States
Address
28210, Wick Road, Romulus, United States
LinkedIn
—
Facebook
—
Phone
+18005377123
PRRC Contact
Jennifer Evans
EUDAMED SRN
US-MF-000043710
FDA FEI Number
1000117344
DUNS Number
—

Catalogue (437)

Page 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
Loupe/Powered Loupe Plano OmniOptic Frame Dragonfly Frame
EUDAMED
Class IActive
ErgoZoom™ Rx .ERGOZOOM.TTL.*, Rx
EUDAMEDFDA UDI
Class IActive
Pinnacle Light Sleeve 3600C
FDA UDI
Class IIActive
Orascoptic - Spark TruColor Headlight System 910133-1
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-7
FDA UDI
Class IActive
CaviCide1 13-5024
FDA UDI
Class IActive
CaviWipes HP 16-1100
FDA UDI
Class IActive
Pinnacle Complete LED Curing Light Sleeve LED250C
FDA UDI
Class IIActive
Dispos-a-Bite 7020
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe .LUXE 2.5.TTL.*, Rx
FDA UDI
Class IActive
Orascoptic - HDL 4.5 HDL 4.5
EUDAMEDFDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910167-2
FDA UDI
Class IActive
CaviWipes 13-1155
FDA UDI
Class IActive
Orascoptic - Dragonfly EyeZoom Rx Dragonfly EyeZoom Rx
EUDAMEDFDA UDI
Class IActive
Orascoptic - Spark Headlight System 910118-32
FDA UDI
Class IActive
Orascoptic - Dragonfly OmniOptic Dragonfly OmniOptic
EUDAMEDFDA UDI
Class IActive
Pinnacle Tube Sleeve 3740C
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 910171-3
FDA UDI
Class IActive
Orascoptic - Endeavour XL Headlight System 910119-48
FDA UDI
Class IActive
CaviWipes 14-1100
FDA UDI
Class IActive
MetriGuard 10-7506
FDA UDI
Class IUnknown
MetriCide 10-602A
FDA UDI
Class IIActive
Dispos-a-Bite 7085
FDA UDI
Class IActive
Orascoptic - Dragonfly EyeZoom Dragonfly EyeZoom
EUDAMEDFDA UDI
Class IActive
CaviWipes 14-1150
FDA UDI
Class IActive
EyeZoom™ Mini Rx - Dragonfly™ .EYEZOOMMINI.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
Endeavour MD 910175-12
FDA UDI
Class IActive
Orascoptic - Dragonfly RDH Elite Dragonfly RDH Elite
EUDAMEDFDA UDI
Class IActive
Pinnacle Cover-All 3710-BC
FDA UDI
Class IIActive
Orascoptic - Spark TruColor Headlight System 910133-21
FDA UDI
Class IActive
Pinnacle Chair Sleeve 3825C
FDA UDI
Class IIActive
EmPower 10-4150
FDA UDI
Class IActive
PerfectPearl Midnight 10-9517
FDA UDI
Class IActive
Spark TruColor 910174-41
FDA UDI
Class IActive
Ease-in-Shields™ 922269-1
FDA UDI
Class IActive
Dispos-a-Bite 7095
FDA UDI
Class IActive
EmPower Fragrance Free 10-4450
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910172-2
FDA UDI
Class IActive
Allrap Protective Barriers SNG150C
FDA UDI
Class IActive
Orascoptic - Endeavour Headlight System 910119-27
FDA UDI
Class IActive
Pinnacle X-Ray Sensor Sheaths PSS3310C
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 910171-2
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-2
FDA UDI
Class IActive
CaviCide1 13-5055
FDA UDI
Class IActive
Orascoptic - HDL 3.0 HDL 3.0
EUDAMEDFDA UDI
Class IActive
XV1™ - Headlight only - Rx .SAFETYGLASSES.XV1.*
FDA UDI
Class IActive
Pinnacle X-Ray Sensor Sheaths PSS3410C
FDA UDI
Class IIActive
Dispos-a-Bite 7090
FDA UDI
Class IActive
Dispos-a-Bite 7040
FDA UDI
Class IActive
Seal-Tight 72200C
FDA UDI
Class IActive

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Metrex Research has three FDA recall records initiated between 2011-09-20 and 2017-01-20, all of which are marked as terminated. The recalls involved Cavicide with Spring Fresh Fragrance due to reported health reactions, Pinnacle Cure Sleeves with incorrect labeling for light guide compatibility, and CaviWipes Extra Large due to potential contamination during packaging.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jan 20, 2017Z-1402-2017—terminated

Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.

Feb 6, 2012Z-2267-2012—terminated

Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and respiratory discomfort.

Sep 20, 2011Z-0444-2013—terminated

The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).