GUDIDData
eudamed_udi Primary ID: 06909262200163

Stemi 305 (UDI 06909262200163)

Manufactured by Carl Zeiss Suzhou Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Stemi 305 - Primary ID 06909262200163

Device Regulatory Overview

The Stemi 305 (Model/Catalog Number: 435063-9010-000) 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
435063-9010-000
Product Code / EMDN
W0202050303
Device Name
Stereomicroscope
Database Sync Date
2026-08-09 16:51:28

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 Stemi 305?

The registered manufacturer of record for Stemi 305 is Carl Zeiss Suzhou Co., Ltd..

What is the Primary UDI-DI identifier for Stemi 305?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06909262200163.

What classification code is assigned to this device?

This device is registered under product classification code W0202050303.

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