eudamed_udi Primary ID: 17090038460051

Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems (UDI 17090038460051)

Manufactured by Gentian AS

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems (Model/Catalog Number: 1100 / A52761) is a medical device manufactured by Gentian AS. This product is indexed under FDA Product Code / Category Classification W0102019008 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0099-2021 View Full Alert →

GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UD...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: 1100 / A52761
Product Code / EMDN: W0102019008
Device Name: Gentian Cystatin C Reagent Kit
Database Sync Date: 2026-08-09 17:04:03

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 Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems?

The registered manufacturer of record for Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems is Gentian AS.

What is the Primary UDI-DI identifier for Gentian Cystatin C Reagent Kit for the Beckman Coulter Synchron Unicel systems?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 17090038460051.

What classification code is assigned to this device?

This device is registered under product classification code W0102019008.

Similar Classification Devices (W0102019008)

Other Devices by Gentian AS

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint