eudamed_udi
Primary ID: 04065803300005
Ambistik (UDI 04065803300005)
Manufactured by Geratherm Respiratory GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ambistik - Primary ID 04065803300005
Device Regulatory Overview
The Ambistik (Model/Catalog Number: 634247) is a medical device manufactured by Geratherm Respiratory GmbH. This product is indexed under FDA Product Code / Category Classification Z12159080 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 634247
- Product Code / EMDN
- Z12159080
- Device Name
- Ambient Sensor
- Database Sync Date
- 2026-08-09 17:31:29
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Ambistik?
The registered manufacturer of record for Ambistik is Geratherm Respiratory GmbH.
What is the Primary UDI-DI identifier for Ambistik?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04065803300005.
What classification code is assigned to this device?
This device is registered under product classification code Z12159080.
Similar Classification Devices (Z12159080)
Other Devices by Geratherm Respiratory GmbH
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