GUDIDData
eudamed_udi Primary ID: 06970229253874

SIH 09 (UDI 06970229253874)

Manufactured by Globalcare Medical Technology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SIH 09 - Primary ID 06970229253874

Device Regulatory Overview

The SIH 09 (Model/Catalog Number: 861.18) is a medical device manufactured by Globalcare Medical Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Z12159002 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
861.18
Product Code / EMDN
Z12159002
Device Name
Aerosoltherapy Nebulizer
Database Sync Date
2026-08-09 16:48:13

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 SIH 09?

The registered manufacturer of record for SIH 09 is Globalcare Medical Technology Co., Ltd..

What is the Primary UDI-DI identifier for SIH 09?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970229253874.

What classification code is assigned to this device?

This device is registered under product classification code Z12159002.

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