GUDIDData
gudid Primary ID: 10401

SICAT OPTISLEEP (UDI 10401)

Manufactured by SiCAT GmbH & Co. KG

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SICAT OPTISLEEP - Primary ID 10401

Device Regulatory Overview

The SICAT OPTISLEEP (Model/Catalog Number: 10401) is a medical device manufactured by SiCAT GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification LRK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
10401
Product Code / EMDN
LRK
Device Name
Database Sync Date
2026-08-09 09:14:54

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 SICAT OPTISLEEP?

The registered manufacturer of record for SICAT OPTISLEEP is SiCAT GmbH & Co. KG.

What is the Primary UDI-DI identifier for SICAT OPTISLEEP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10401.

What classification code is assigned to this device?

This device is registered under product classification code LRK.

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