GUDIDData
eudamed_udi Primary ID: 08681812530668

LDL KOLESTEROL DİREKT KİTİ (UDI 08681812530668)

Manufactured by ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for LDL KOLESTEROL DİREKT KİTİ - Primary ID 08681812530668

Device Regulatory Overview

The LDL KOLESTEROL DİREKT KİTİ (Model/Catalog Number: 08V4920) is a medical device manufactured by ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ. This product is indexed under FDA Product Code / Category Classification W01010221 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
08V4920
Product Code / EMDN
W01010221
Device Name
LDL CHOLESTEROL DIRECT REAGENT
Database Sync Date
2026-08-09 16:29:02

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 LDL KOLESTEROL DİREKT KİTİ?

The registered manufacturer of record for LDL KOLESTEROL DİREKT KİTİ is ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ.

What is the Primary UDI-DI identifier for LDL KOLESTEROL DİREKT KİTİ?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08681812530668.

What classification code is assigned to this device?

This device is registered under product classification code W01010221.

Programmatic Export

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

JSON API Endpoint