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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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Z5-BL-4012 — 1 UDI-DI variant, MDD (Z-Systems AG)

MD Atlas
Z-Systems AG

Data from EUDAMED, last updated May 31, 2026

Z5-BL-4012

B-07640166760825

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class IIb

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Manufacturer: Z-Systems AG

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Device characteristics

Implantable

Legacy certificates

Certificate number: 45299
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: Schweizerische Vereinigung für Qualitäts- und Managementsysteme (1250)
Validity: Nov 15, 2023

Identity & classification

Basic UDI-DI: B-07640166760825
Device name: Z5-BL-4012
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIb
Version date: Apr 20, 2026

Manufacturer & authorised representative

Manufacturer

Name: Z-Systems AG
SRN: CH-MF-000029012
Country: Switzerland
Email: quality@zsystems.com

Authorised representative

Name: Axxos GmbH
SRN: DE-AR-000005590
Country: Germany
Phone: +41795637850

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KPNQRGXHA01KQK2CKG3E5XKE

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

Z5-BL-401207640166760825