GUDIDData
eudamed_udi Primary ID: 05033435139125

Unifit (UDI 05033435139125)

Manufactured by TensCare Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unifit - Primary ID 05033435139125

Device Regulatory Overview

The Unifit (Model/Catalog Number: K-UNIFIT) is a medical device manufactured by TensCare Ltd. This product is indexed under FDA Product Code / Category Classification Z12062801 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
K-UNIFIT
Product Code / EMDN
Z12062801
Device Name
Unifit
Database Sync Date
2026-08-09 16:49:29

Full Regulatory Attributes

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{
    "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 Unifit?

The registered manufacturer of record for Unifit is TensCare Ltd.

What is the Primary UDI-DI identifier for Unifit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05033435139125.

What classification code is assigned to this device?

This device is registered under product classification code Z12062801.

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