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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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Direct Driver — 2 UDI-DI variants, MDR (Bioretec Ltd.)

MD Atlas
Bioretec Ltd.

Data from EUDAMED, last updated May 23, 2026

Direct Driver

6438394INS009WW

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Bioretec Ltd.

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Device characteristics

Reusable

Identity & classification

Basic UDI-DI: 6438394INS009WW
Device name: Direct Driver
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jan 24, 2023

Manufacturer & authorised representative

Manufacturer

Name: Bioretec Ltd.
SRN: FI-MF-000001328
Country: Finland
Email: sales@bioretec.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01GQHVCJSK5MAS1943M1C71M9N

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

B-ISC-350206438394005228
B-ISC-450206438394005235