Amplio™ Digital Visualization System Kit

FDA UDI

Class I (US FDA UDI)

by Unify Medical

Identity

Trade Name: Amplio™ Digital Visualization System Kit FDA UDI
Generic Name: General-purpose surgical microscope FDA UDI
Device Name: Visulaization Headset, Syspack, Wired Controller, Headset Cable, and Belt FDA UDI
Model / Reference: AMP-001 FDA UDI
Description: Visulaization Headset, Syspack, Wired Controller, Headset Cable, and Belt FDA UDI

Identifiers

Primary DI / UDI-DI: 00860011130727 FDA UDI
FDA Product Code: FSO FDA UDI
GMDN Term: General-purpose surgical microscope FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose surgical microscope

Amplio™ Digital Visualization System Kit by Unify Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical microscope.

FIXED 45 DEGREE INCLINED BINOCULAR, A-SERIES, 10X EYEPIECES, F:160 — GLOBAL SURGICAL CORP. · Class I
MAGEWELL IMAGE CAPTURE KIT WITH USB3 CABLE, AIRMOUSE, AND SOFTWARE — GLOBAL SURGICAL CORP. · Class I
OSM200 Stand — Prescott'S, Inc. · Class I
SILICONE EYEGUARD, LOW PROFILE, FOR OLD STYLE EYEPIECES — GLOBAL SURGICAL CORP. · Class I
MICROSCOPE — Ecleris · Class I
MICROSCOPE — Ecleris · Class I
S7 / OPMI PROergo — Carl Zeiss Meditec AG · Class I
A-SERIES CEILING MOUNT, STANDARD DROP CEILING — GLOBAL SURGICAL CORP. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Unify Medical

Sources (1)

FDA UDI fd252dbc-0d58-4bcd-b9a1-1380f21ef870 33 fields · synced Jun 8, 2026