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Ultra Laboratory Information System

FDA UDI

Class I (US FDA UDI)

by Cirdan Imaging Limited

Identity

Trade Name
Ultra Laboratory Information System FDA UDI
Generic Name
Clinical laboratory information system application software FDA UDI
Device Name
Digital image, storage and communication, non-diagnostic, laboratory information system FDA UDI
Model / Reference
4.1 FDA UDI
Description
Digital image, storage and communication, non-diagnostic, laboratory information system FDA UDI

Identifiers

Primary DI / UDI-DI
05060508820024 FDA UDI
FDA Product Code
NVV FDA UDI
GMDN Term
Clinical laboratory information system application software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2100 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Clinical laboratory information system application software

Ultra Laboratory Information System by Cirdan Imaging Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical laboratory information system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cirdan Imaging Limited

Sources (1)

  • FDA UDI 2af0c9e1-9c93-4304-a8a3-d5e761a963c8 33 fields · synced May 30, 2026