← Back to catalogue

Is-5500

FDA UDI

Class I (US FDA UDI)

by Topcon Healthcare, Inc.

Identity

Trade Name
IS-5500 FDA UDI
Generic Name
Static ophthalmic equipment stand, manually-adjusted FDA UDI
Device Name
IS-5500 OPHTHALMIC INST. STAND W/DLRL 22; AC-Powered Ophthalmic Instrument Stand FDA UDI
Model / Reference
23060-22-001 FDA UDI
Description
IS-5500 OPHTHALMIC INST. STAND W/DLRL 22; AC-Powered Ophthalmic Instrument Stand FDA UDI

Identifiers

Primary DI / UDI-DI
00852683007131 FDA UDI
FDA Product Code
HMF FDA UDI
GMDN Term
Static ophthalmic equipment stand, manually-adjusted FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.1860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Static ophthalmic equipment stand, manually-adjusted

Is-5500 by Topcon Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Static ophthalmic equipment stand, manually-adjusted.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Topcon Healthcare, Inc.

Sources (1)

  • FDA UDI e928e9f7-0074-47f5-a43e-99927f588f01 33 fields · synced May 30, 2026