eudamed_udi
Primary ID: 05713315005893
HB‑8 Headband (8 kHz) (UDI 05713315005893)
Manufactured by Natus Medical Denmark ApS
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HB‑8 Headband (8 kHz) - Primary ID 05713315005893
Device Regulatory Overview
The HB‑8 Headband (8 kHz) (Model/Catalog Number: 8-75-435) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification Z121401 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8-75-435
- Product Code / EMDN
- Z121401
- Device Name
- TDH 39 Headphones (HB‑7)
- Database Sync Date
- 2026-08-09 16:50:58
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 HB‑8 Headband (8 kHz)?
The registered manufacturer of record for HB‑8 Headband (8 kHz) is Natus Medical Denmark ApS.
What is the Primary UDI-DI identifier for HB‑8 Headband (8 kHz)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05713315005893.
What classification code is assigned to this device?
This device is registered under product classification code Z121401.
Similar Classification Devices (Z121401)
Other Devices by Natus Medical Denmark ApS
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