GUDIDData
gudid Primary ID: 002-22-000009HD

Cleo (UDI 002-22-000009HD)

Manufactured by AMERICAN ORTHODONTICS CORPORATION

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Cleo - Primary ID 002-22-000009HD

Device Regulatory Overview

The Cleo (Model/Catalog Number: 002-22-000009HD) is a medical device manufactured by AMERICAN ORTHODONTICS CORPORATION. This product is indexed under FDA Product Code / Category Classification NJM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
002-22-000009HD
Product Code / EMDN
NJM
Device Name
COSMETIC CLEO UR BIC 022 T-7 A=0 R=0 W/HK DIST
Database Sync Date
2026-08-09 09:00:42

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Cleo?

The registered manufacturer of record for Cleo is AMERICAN ORTHODONTICS CORPORATION.

What is the Primary UDI-DI identifier for Cleo?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 002-22-000009HD.

What classification code is assigned to this device?

This device is registered under product classification code NJM.

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