eudamed_udi Primary ID: 06909262200194

Primostar 3 (UDI 06909262200194)

Manufactured by Carl Zeiss Suzhou Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Primostar 3 (Model/Catalog Number: 415501-0081-000) is a medical device manufactured by Carl Zeiss Suzhou Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0202050303 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-0183-2024 View Full Alert →

OPMI LUMERA 300, REF 6137...

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Technical Specifications

Model Number: 415501-0081-000
Product Code / EMDN: W0202050303
Device Name: Upright microscope
Database Sync Date: 2026-08-09 16:48:56

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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Frequently Asked Questions

Who is the primary manufacturer of Primostar 3?

The registered manufacturer of record for Primostar 3 is Carl Zeiss Suzhou Co., Ltd..

What is the Primary UDI-DI identifier for Primostar 3?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06909262200194.

What classification code is assigned to this device?

This device is registered under product classification code W0202050303.

Similar Classification Devices (W0202050303)

Other Devices by Carl Zeiss Suzhou Co., Ltd.

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