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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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Occlutech Sizing Balloon — 2 UDI-DI variants, MDR (Occlutech GmbH)

MD Atlas
Occlutech GmbH

Data from EUDAMED, last updated May 23, 2026

Occlutech Sizing Balloon

426018252OSBF4

2 UDI-DI variants

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

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

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: 51030-60-00
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: DEKRA Certification GmbH (0124)
Validity: Sep 2, 2022 → Oct 19, 2026

Certificate number: 51030-61-C0
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: DEKRA Certification GmbH (0124)
Validity: Jun 29, 2023 → Jun 28, 2028

Identity & classification

Basic UDI-DI: 426018252OSBF4
Device name: Occlutech Sizing Balloon
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: Sep 17, 2024

Manufacturer & authorised representative

Manufacturer

Name: Occlutech GmbH
SRN: DE-MF-000005104
Country: Germany
Email: info-jena@occlutech.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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basicUdiUlid01J7ZGDTJMKDKHR790A48CCPS1

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

53SB35504260182521854
53SB25404260182521847