gudid
Primary ID: Envoy 500+
Envoy (UDI Envoy 500+)
Manufactured by BIOTECNICA INSTRUMENTS SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Envoy - Primary ID Envoy 500+
Device Regulatory Overview
The Envoy (Model/Catalog Number: Envoy 500+) is a medical device manufactured by BIOTECNICA INSTRUMENTS SPA. This product is indexed under FDA Product Code / Category Classification JJE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Envoy 500+
- Product Code / EMDN
- JJE
- Device Name
- Multiple clinical chemistry analyser IVD, laboratory, semi-automated:An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
- Database Sync Date
- 2026-08-09 09:04:39
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 Envoy?
The registered manufacturer of record for Envoy is BIOTECNICA INSTRUMENTS SPA.
What is the Primary UDI-DI identifier for Envoy?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Envoy 500+.
What classification code is assigned to this device?
This device is registered under product classification code JJE.
Similar Classification Devices (JJE)
Other Devices by BIOTECNICA INSTRUMENTS SPA
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