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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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BioniQ Instruments, Non-active… — 3 UDI-DI variants, MDR

MD Atlas
LASAK s.r.o.

Data from EUDAMED, last updated May 23, 2026

BioniQ Instruments, Non-active non-implantable instruments

85955730047YA

3 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: LASAK s.r.o.

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Device characteristics

Reusable

Legacy certificates

Certificate number: 2023-MDR/QS-041
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: 3EC International a.s. (2265)
Validity: Oct 27, 2023 → Oct 27, 2028

Identity & classification

Basic UDI-DI: 85955730047YA
Device name: BioniQ Instruments, Non-active non-implantable instruments
Device model: Insertion wrench BioniQ for guided surgery; Insertion wrench
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jun 5, 2025

Manufacturer & authorised representative

Manufacturer

Name: LASAK s.r.o.
SRN: CZ-MF-000031907
Country: Czechia
Email: info@lasak.cz

Variants by status

UDI-DI variants

3 UDI-DI variants

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basicUdiUlid01JX0185CTC7Q1FZEC9YEW0473

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

Insertion wrench BioniQ – extra short08595573002268
Insertion wrench BioniQ – long08595573002251
Insertion wrench BioniQ for guided surgery (GS)08595573002398