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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 6 of 9
DeviceModel / ReferenceRegistriesClassStatus
Spark™ 922243-2
FDA UDI
N/AActive
HDL™ 3.5 Rx - XV1™ .HDL 3.5.TTL.XV1.*, Rx
FDA UDI
Class IActive
CaviCide1 13-5002
FDA UDI
Class IActive
Orascoptic - OmniOptic HDL 5.5 OmniOptic HDL 5.5
EUDAMEDFDA UDI
Class IActive
Orascoptic - Endeavour Headlight System 910119-10
FDA UDI
Class IActive
Seal-Tight 77200C
FDA UDI
Class IActive
Allrap Protective Barriers SS500C
FDA UDI
Class IActive
HDL™ 2.5 Macro Rx - Dragonfly™ .HDL 2.5 MACRO.TTL.DRAGONFLY * (GEN 2).*, Rx
FDA UDI
Class IActive
MetriCide28 10-2800
FDA UDI
Class IIActive
Endeavour MD 910176-11
FDA UDI
Class IActive
MetriZyme 10-4000
FDA UDI
Class IActive
Orascoptic - Dragonfly HDL 3.5 Dragonfly HDL 3.5
EUDAMEDFDA UDI
Class IActive
Allrap Protective Barriers SS500XLC
FDA UDI
Class IActive
Luxe™ 2.5 Semi-custom loupe 910173-3
FDA UDI
Class IActive
Ease-in-Shields™ 922269-2
FDA UDI
Class IActive
Dragonfly™ - Headlight only - Rx .SAFETYGLASSES.DRAGONFLY.*
FDA UDI
Class IActive
CaviCide 13-1002
FDA UDI
Class IActive
EyeZoom™ Mini Rx - XV1™ .EYEZOOMMINI.TTL.XV1.*, Rx
FDA UDI
Class IActive
MetriCide Plus 30 10-3200
FDA UDI
Class IIActive
CaviCide HP 16-1000
FDA UDI
Class IActive
Pinnacle Tube Sleeve 3720C
FDA UDI
Class IIActive
MetriWash 10-3300
FDA UDI
Class IActive
ErgoZoom™ Plano .ERGOZOOM.TTL.*, Plano
EUDAMEDFDA UDI
Class IActive
MetriZyme 10-4005
FDA UDI
Class IActive
MetriClean 2 10-8100
FDA UDI
Class IActive
Pinnacle X-Ray Sensor Sheaths PSS3420C
FDA UDI
Class IIActive
ProCide-D 10-2865
FDA UDI
Class IIActive
Orascoptic - HDL 3.5 HDL 3.5
EUDAMEDFDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-41
FDA UDI
Class IActive
Endeavour MD 910175-1
FDA UDI
Class IActive
Pinnacle Tray Sleeve 3500-MC
FDA UDI
Class IIActive
Pinnacle No-Slip Chair Sleeve 3870-NSC
FDA UDI
Class IIActive
Endeavour™ TruColor™ 910177-3
FDA UDI
Class IActive
EmPower 10-4102
FDA UDI
Class IActive
Pinnacle X-Ray Sensor Sheaths PSS3350C
FDA UDI
Class IIActive
Orascoptic - Dragonfly HDL 5.5 Rx Dragonfly HDL 5.5 Rx
EUDAMEDFDA UDI
Class IActive
Orascoptic - Endeavour XL Headlight System 910119-41
FDA UDI
Class IActive
Dispos-a-Bite 7030
FDA UDI
Class IActive
CaviCide 13-1008
FDA UDI
Class IActive
Endeavour™ TruColor™ 910177-4
FDA UDI
Class IActive
HDL Ergo 5.0 Rx HDL Ergo 5.0 Rx
FDA UDI
Class IActive
Orascoptic - Endeavour TruColor XL Headlight System 910131-45
FDA UDI
Class IActive
Orascoptic - EyeZoom Max EyeZoom Max
EUDAMEDFDA UDI
Class IActive
CaviWipes 13-1100
FDA UDI
Class IActive
Orascoptic - HDL 3.0 Rx HDL 3.0 Rx
EUDAMEDFDA UDI
Class IActive
Dexis Platinum Sensor Sheaths PLU975019C
FDA UDI
Class IIActive
Spree 66150C
FDA UDI
Class IActive
Orascoptic - Spark TruColor Headlight System 910133-41
FDA UDI
Class IActive
CaviCide1 13-5008
FDA UDI
Class IActive
Spark TruColor 910174-2
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).