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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 3 of 9
DeviceModel / ReferenceRegistriesClassStatus
MetriCide28 10-2805
FDA UDI
Class IIActive
Luxe™ 2.5 Semi-custom loupe 910173-2
FDA UDI
Class IActive
CaviWipes 10-1090
FDA UDI
Class IActive
HDL™ 3.5 Prism Plano - Dragonfly™ .HDL 3.5.TTL.DRAGONFLY * (GEN 2).*, Plano
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910170-2
FDA UDI
Class IActive
PerfectPearl Classic 10-9515
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910165-2
FDA UDI
Class IActive
Orascoptic - HDL 2.5 Micro Rx HDL 2.5 Micro Rx
FDA UDI
Class IActive
Envirocide 13-3300
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-8
FDA UDI
Class IActive
CaviWipes 13-1224
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-1
FDA UDI
Class IActive
Orascoptic - Endeavour XL Headlight System 910119-43
FDA UDI
Class IActive
Safe-Tips EZ 44600C
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910169-2
FDA UDI
Class IActive
HDL™ 3.0 Rx - XV1™ .HDL 3.0.TTL.XV1.*, Rx
FDA UDI
Class IActive
Allrap Protective Barriers TLC500C
FDA UDI
Class IActive
EmPower 10-4100
FDA UDI
Class IActive
CaviWipes 13-9100
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-30
FDA UDI
Class IActive
Spark TruColor 910174-1
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-68
FDA UDI
Class IActive
MetriWash 10-3315
FDA UDI
Class IActive
MetriClean 2 10-8150
FDA UDI
Class IActive
Pinnacle Temple Guard 7300C
FDA UDI
Class IIActive
Petite Pearl 10-9532
FDA UDI
Class IActive
Pinnacle X-Ray Sleeve XL 3950-XLC
FDA UDI
Class IIActive
Orascoptic - Dragonfly HDL 3.0 Dragonfly HDL 3.0
EUDAMEDFDA UDI
Class IActive
Orascoptic - Spark Headlight System 910118-31
FDA UDI
Class IActive
CaviWipesXL 13-1150
FDA UDI
Class IActive
Allrap Protective Barriers LS500C
FDA UDI
Class IActive
ErgoZoom™ Rx - Dragonfly™ .ERGOZOOM.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IUnknown
Orascoptic - HDL 2.5 Micro HDL 2.5 Micro
FDA UDI
Class IActive
Orascoptic - Dragonfly HDL 2.5 Micro Rx Dragonfly HDL 2.5 Micro Rx
FDA UDI
Class IActive
ProCide-D Plus 10-3260
FDA UDI
Class IIActive
Orascoptic - Dragonfly RDH Ergo 3.0 Rx Dragonfly RDH Ergo 3.0 Rx
EUDAMEDFDA UDI
Class IActive
Orascoptic - Safety Frame Rx Safety Frame Rx
EUDAMEDFDA UDI
Class IActive
MetriCide OPA Plus 10-6000
FDA UDI
Class IIActive
PerfectPearl Midnight 10-9521
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor Headlight System 910131-10
FDA UDI
Class IActive
EyeZoom™ Rx - Dragonfly™ .EYEZOOM.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
EmPower 10-4130
FDA UDI
Class IActive
Spark TruColor 910174-11
FDA UDI
Class IActive
HDL™ 4.5 Rx - XV1™ .HDL 4.5.TTL.XV1.*, Rx
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910169-1
FDA UDI
Class IActive
Pinnacle Tray Sleeve 3200-EC
FDA UDI
Class IIActive
Orascoptic - OmniOptic Rx OmniOptic Rx
EUDAMEDFDA UDI
Class IActive
PerfectPearl Classic 10-9513
FDA UDI
Class IActive
RDH™ 2.5 Plano - Dragonfly™ .RDH.TTL.DRAGONFLY * (GEN 2).*, Plano
FDA UDI
Class IActive
HDL™ 3.0 Plano - XV1™ .HDL 3.0.TTL.XV1.*, Plano
FDA UDI
Class IActive

Related Companies

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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).