gudid
Primary ID: TL-061S
NA (UDI TL-061S)
Manufactured by NIHON KOHDEN CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NA - Primary ID TL-061S
Device Regulatory Overview
The NA (Model/Catalog Number: TL-061S) is a medical device manufactured by NIHON KOHDEN CORPORATION. This product is indexed under FDA Product Code / Category Classification DRG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- TL-061S
- Product Code / EMDN
- DRG
- Device Name
- SpO2 probe, Child (from 15 to 50 kg) fingerInfant (from 3 to 15 kg) toe, disposable
- Database Sync Date
- 2026-08-09 09:29:18
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 NA?
The registered manufacturer of record for NA is NIHON KOHDEN CORPORATION.
What is the Primary UDI-DI identifier for NA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is TL-061S.
What classification code is assigned to this device?
This device is registered under product classification code DRG.
Similar Classification Devices (DRG)
Other Devices by NIHON KOHDEN CORPORATION
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