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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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POL1-Z-Series — 2 UDI-DI variants, MDR (FUJIFILM medwork GmbH)

MD Atlas
FUJIFILM medwork GmbH

Data from EUDAMED, last updated May 23, 2026

POL1-Z-Series

4044503060483U

2 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: FUJIFILM medwork GmbH

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 1000297126
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: DQS Medizinprodukte GmbH (0297)
Validity: Jan 29, 2026 → Oct 1, 2028

Identity & classification

Basic UDI-DI: 4044503060483U
Device name: POL1-Z-Series
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 8, 2026

Manufacturer & authorised representative

Manufacturer

Name: FUJIFILM medwork GmbH
SRN: DE-MF-000008444
Country: Germany
Email: info_ffmw@fujifilm.com
Phone: +49 91 93 500 900

Variants by status

UDI-DI variants

2 UDI-DI variants

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basicUdiUlid01KEESFRQTBW1AS7TH12FE9AT4

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

7010014774204044503055897
7010014774304044503055903