GN Otometrics A/S (UDI "Headset HB-7 (8 kHz) matched)
Manufactured by Natus Medical Denmark ApS
Device Regulatory Overview
The GN Otometrics A/S (Model/Catalog Number: "Headset HB-7 (8 kHz) matched) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification ETY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- "Headset HB-7 (8 kHz) matched
- Product Code / EMDN
- ETY
- Device Name
- Headset HB-7 (8 kHz) matched TDH39 phones (jack)
- Database Sync Date
- 2026-08-09 09:12:40
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 GN Otometrics A/S?
The registered manufacturer of record for GN Otometrics A/S is Natus Medical Denmark ApS.
What is the Primary UDI-DI identifier for GN Otometrics A/S?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is "Headset HB-7 (8 kHz) matched.
What classification code is assigned to this device?
This device is registered under product classification code ETY.
Similar Classification Devices (ETY)
Other Devices by Natus Medical Denmark ApS
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