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REVMEDX, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
25749 SW CANYON CREEK RD STE 300, Wilsonville, OR, 97070
Website
revmedx.com
LinkedIn
—
Facebook
—
Phone
503-218-2172
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3009035955
DUNS Number
961523441

Catalogue (12)

DeviceModel / ReferenceRegistriesClassStatus
Xstat XSTAT 30
FDA UDI
Class IIUnknown
Xstat XSTAT 12
FDA UDI
Class IIActive
Xstat XSTAT-30 Gen 2
FDA UDI
Class IActive
Xstat P30 FIN-0017-21
FDA UDI
Class IIActive
AirWrap FIN-0005-01
FDA UDI
Class IActive
Xstat DEN130016
FDA 510(k)
Class IIActive
XSTAT 30 Pouch K210676
FDA 510(k)
Class IIActive
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack K161020
FDA 510(k)
Class IIActive
XSTAT 30, 1-Pack K180051
FDA 510(k)
Class IIActive
XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack K170334
FDA 510(k)
Class IIActive
Xstat 30, 3-Pack, Xstat 30, 1-Pack K152624
FDA 510(k)
Class IIActive
Xstat P15 K253290
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

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

DateRecall No.ClassStatusReason
Aug 12, 2015Z-2762-2015—terminated

The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile.