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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 5 of 9
DeviceModel / ReferenceRegistriesClassStatus
HDL™ 5.5 Prism Rx - Dragonfly™ .HDL 5.5.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
Pinnacle Sensor Cover 3735C
FDA UDI
Class IIActive
CaviWipes 13-5155
FDA UDI
Class IActive
Orascoptic - HDL 3.5 Rx HDL 3.5 Rx
EUDAMEDFDA UDI
Class IActive
HDL™ 4.5 Plano - XV1™ .HDL 4.5.TTL.XV1.*, Plano
FDA UDI
Class IActive
Orascoptic - OmniOpti HDL 2.5 OmniOpti HDL 2.5
FDA UDI
Class IActive
Orascoptic - HDL 3.5 Galilean HDL 3.5 Galilean
FDA UDI
Class IActive
Allrap Protective Barriers TS115-16C
FDA UDI
Class IActive
Orascoptic - EyeZoom Mini EyeZoom Mini
EUDAMEDFDA UDI
Class IActive
Orascoptic - RDH Ergo 3.0 RDH Ergo 3.0
EUDAMEDFDA UDI
Class IActive
Endeavour™ XL 910119-121
FDA UDI
Class IActive
Orascoptic - HDL 5.5 HDL 5.5
EUDAMEDFDA UDI
Class IActive
Orascoptic - Dragonfly HDL 2.5 Micro Dragonfly HDL 2.5 Micro
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-25
FDA UDI
Class IActive
Metricide 10-602
FDA UDI
Class IIActive
Orascoptic - EyeZoom EyeZoom
FDA UDI
Class IActive
HDL™ 2.5 Macro Plano - XV1™ .HDL 2.5 MACRO.TTL.XV1.*, Plano
FDA UDI
Class IActive
Allrap Protective Barriers 460BC
FDA UDI
Class IActive
EyeZoom™ Plano - XV1™ .EYEZOOM.TTL.XV1.*, Plano
FDA UDI
Class IActive
Orascoptic - Dragonfly HDL 2.5 Macro Rx Dragonfly HDL 2.5 Macro Rx
EUDAMEDFDA UDI
Class IActive
Spark TruColor 910174-21
FDA UDI
Class IActive
Orascoptic - Endeavour Headlight System 910119-7
FDA UDI
Class IActive
HDL™ 5.5 Prism Plano - Dragonfly™ .HDL 5.5.TTL.DRAGONFLY * (GEN 2).*, Plano
FDA UDI
Class IActive
CaviCide1 13-5025
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910165-1
FDA UDI
Class IActive
Pinnacle Chin Guard 7200C
FDA UDI
Class IIActive
HDL™ 3.0 Rx - Dragonfly™ .HDL 3.0.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-42
FDA UDI
Class IActive
Orascoptic - Spark TruColor Headlight System 910133-22
FDA UDI
Class IActive
HDL Ergo 5.0 Rx - Dragonfly HDL Ergo 5.0 Rx - Dragonfly
EUDAMEDFDA UDI
Class IActive
Endeavour MD 910175-2
FDA UDI
Class IActive
XV1™ / Dragonfly™ 922122-1
FDA UDI
N/AActive
Orascoptic - Dragonfly EyeZoom Max Rx Dragonfly EyeZoom Max Rx
EUDAMEDFDA UDI
Class IActive
Orascoptic - Spark TruColor Headlight System 910133-42
FDA UDI
Class IActive
Compliance 10-2500
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 922464-2
FDA UDI
Class IActive
CaviWipes HP 16-1150
FDA UDI
Class IActive
Orascoptic - Safety Frame Safety Frame
EUDAMEDFDA UDI
Class IActive
Ball-Point Applicators 8300-FC
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910173-1
FDA UDI
Class IActive
Orascoptic - HDL Ergo 3.5 HDL Ergo 3.5
EUDAMEDFDA UDI
Class IActive
Pinnacle X-Ray Sensor Sheath PSS3100C
FDA UDI
Class IIActive
Pinnacle Drape-It-All 3770C
FDA UDI
Class IIActive
ProCide-D 10-2860
FDA UDI
Class IIActive
HDL™ 3.5 Plano - XV1™ .HDL 3.5.TTL.XV1.*, Plano
FDA UDI
Class IActive
Pinnacle Complete Curing Light Sleeve CLS250C
EUDAMEDFDA UDI
Class IIActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-50
FDA UDI
Class IActive
CaviCide1 13-5000
FDA UDI
Class IActive
Orascoptic - EyeZoom Mini Rx EyeZoom Mini Rx
EUDAMEDFDA UDI
Class IActive
CaviWipes1 13-5100
FDA UDI
Class IActive

Related Companies

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Importers

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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).