GUDIDData
gudid Primary ID: SHWM01L8

LOWER LIMB KIT 8 WISE (UDI SHWM01L8)

Manufactured by NCS LAB SRL

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LOWER LIMB KIT 8 WISE - Primary ID SHWM01L8

Device Regulatory Overview

The LOWER LIMB KIT 8 WISE (Model/Catalog Number: SHWM01L8) is a medical device manufactured by NCS LAB SRL. This product is indexed under FDA Product Code / Category Classification ISD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SHWM01L8
Product Code / EMDN
ISD
Device Name
The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district.
Database Sync Date
2026-08-09 09:04:32

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 LOWER LIMB KIT 8 WISE?

The registered manufacturer of record for LOWER LIMB KIT 8 WISE is NCS LAB SRL.

What is the Primary UDI-DI identifier for LOWER LIMB KIT 8 WISE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SHWM01L8.

What classification code is assigned to this device?

This device is registered under product classification code ISD.

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