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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 8 of 9
DeviceModel / ReferenceRegistriesClassStatus
Orascoptic - Endeavour Headlight System 910119-21
FDA UDI
Class IActive
ProCide-D Plus 10-3265
FDA UDI
Class IIActive
Metritest 10-303
FDA UDI
Class IIActive
PerfectPearl Midnight 10-9519
FDA UDI
Class IActive
MetriZyme 10-4050
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910167-3
FDA UDI
Class IActive
Pinnacle Syringe Sleeve 3760C
FDA UDI
Class IIActive
Orascoptic - HDL 5.5 Rx HDL 5.5 Rx
EUDAMEDFDA UDI
Class IActive
HDL™ 5.5 Rx - XV1™ .HDL 5.5.TTL.XV1.*, Rx
FDA UDI
Class IActive
RDH™ 2.5 Rx - Dragonfly™ .RDH.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
HDL™ 2.5 Micro Rx - XV1™ .HDL 2.5 MICRO.TTL.XV1.*, Rx
FDA UDI
Class IActive
Pinnacle Headrest Cover 3514C
FDA UDI
Class IIActive
Spark TruColor 910174-42
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-64
FDA UDI
Class IActive
HDL™ 2.5 Macro Plano .HDL 2.5 MACRO.TTL.*, Plano
EUDAMEDFDA UDI
Class IActive
Pinnacle Cure Sleeve 4513C
FDA UDI
Class IIActive
Orascoptic - Spark TruColor Headlight System 910133-2
FDA UDI
Class IActive
Allrap Protective Barriers SNG2980C
FDA UDI
Class IActive
Orascoptic - EyeZoom Max Plano - XV1 EyeZoom Max Plano - XV1
FDA UDI
Class IActive
Orascoptic - Endeavour XL Headlight System 910119-46
FDA UDI
Class IActive
MetriClean 2 10-8130
FDA UDI
Class IActive
ErgoZoom™ Plano - Dragonfly™ .ERGOZOOM.TTL.DRAGONFLY * (GEN 2).*, Plano
FDA UDI
Class IActive
Orascoptic - Dragonfly OmniOptic Rx Dragonfly OmniOptic Rx
EUDAMEDFDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-47
FDA UDI
Class IActive
Spark TruColor 910174-31
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910166-1
FDA UDI
Class IActive
Orascoptic - OmniOptic OmniOptic
EUDAMEDFDA UDI
Class IActive
Pinnacle Sensor Cover 3736C
FDA UDI
Class IIActive
Orascoptic - Endeavour XL Headlight System 910119-50
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910167-1
FDA UDI
Class IActive
Pinnacle Tray Sleeve 3000-BC
FDA UDI
Class IIActive
Pinnacle Impression Gun Cover 4600C
FDA UDI
Class IIActive
Metritest 10-304
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 910166-3
FDA UDI
Class IActive
Dispos-a-Bite 7050
FDA UDI
Class IActive
Pinnacle Light Sleeve 3650C
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 910172-1
FDA UDI
Class IActive
OmniOptic™ Rx - Dragonfly™ .*.OMNI.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
HDL™ Ergo 5.0 Rx - Dragonfly™ .HDL ERGO 5.0.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
EyeZoom™ Mini Plano - XV1™ .EYEZOOMMINI.TTL.XV1.*, Plano
FDA UDI
Class IActive
CaviWipes1 XL 13-5150
FDA UDI
Class IActive
Orascoptic - Dragonfly RDH Elite Rx Dragonfly RDH Elite Rx
EUDAMEDFDA UDI
Class IActive
CaviCide 13-1055
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910168-3
FDA UDI
Class IActive
OmniOptic™ Ocular Pair - HDL™ 2.5 Rx .HDL 2.5 MACRO.OMNI.OCULAR ONLY.*
EUDAMEDFDA UDI
Class IActive
Orascoptic - Spark Headlight System 910118-22
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-44
FDA UDI
Class IActive
Universal Flip - Rx .UNIVERSAL.FLIP.TITAN.ONE-SIZE.*
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-6
FDA UDI
Class IActive
OmniOptic™ Rx - XV1™ .*.OMNI.XV1.*, Rx
FDA UDI
Class IActive

Related Companies

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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).