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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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Implantable Pacemaker System with a… — 1 UDI-DI variant, AIMDD

MD Atlas
MicroPort CRM S.r.l.

Data from EUDAMED, last updated May 31, 2026

Implantable Pacemaker System with a conditional intended use in MRI environment - KORA

B-08031527012735

1 UDI-DI variant

AIMDD [Directive 90/385/EEC on active implantable medical devices]AIMDD

Legislation: AIMDD [Directive 90/385/EEC on active implantable medical devices]
Risk class: AIMDD
Manufacturer: MicroPort CRM S.r.l.

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Device characteristics

Active deviceImplantable

Legacy certificates

Certificate number: I7 005178 0010
Type: refdata.legacy.aimdd-certificate-type.ii-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: Nov 15, 2023

Certificate number: I1 005178 0001
Type: refdata.legacy.aimdd-certificate-type.ii-excluding-4
Notified body: TÜV SÜD Product Service GmbH (0123)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-08031527012735
Device name: Implantable Pacemaker System with a conditional intended use in MRI environment - KORA
Device model: KORA 100 SR
Issuing agency: EUDAMED
Legislation: AIMDD [Directive 90/385/EEC on active implantable medical devices]
Risk class: AIMDD
Version date: May 4, 2026

Manufacturer & authorised representative

Manufacturer

Name: MicroPort CRM S.r.l.
SRN: IT-MF-000029013
Country: Italy
Email: contact@crm.microport.com

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KQSMMTCYXK6ZBJJ0T5X54CF4

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

TPM007C08031527012735