gudid
Primary ID: SmartCare Transmitter
TENA (UDI SmartCare Transmitter)
Manufactured by Essity Hygiene and Health AB
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TENA - Primary ID SmartCare Transmitter
Device Regulatory Overview
The TENA (Model/Catalog Number: SmartCare Transmitter) is a medical device manufactured by Essity Hygiene and Health AB. This product is indexed under FDA Product Code / Category Classification KPN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- SmartCare Transmitter
- Product Code / EMDN
- KPN
- Device Name
- The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems.
- Database Sync Date
- 2026-08-09 09:41:28
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of TENA?
The registered manufacturer of record for TENA is Essity Hygiene and Health AB.
What is the Primary UDI-DI identifier for TENA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SmartCare Transmitter.
What classification code is assigned to this device?
This device is registered under product classification code KPN.
Similar Classification Devices (KPN)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint