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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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Lumorinse — 2 UDI-DI variants, MDR (Koite Health Oy)

MD Atlas
Koite Health Oy

Data from EUDAMED, last updated May 23, 2026

Lumorinse

6429810197Lumorinsetabl4P

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Koite Health Oy

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: FI25/00000056
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: SGS FIMKO OY (0598)
Validity: Oct 24, 2025 → Oct 6, 2028

Identity & classification

Basic UDI-DI: 6429810197Lumorinsetabl4P
Device name: Lumorinse
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jul 3, 2024

Manufacturer & authorised representative

Manufacturer

Name: Koite Health Oy
SRN: FI-MF-000006901
Country: Finland
Email: sakari@koitehealth.com
Phone: +358408222034

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01J1WACWQZK2FJDC2DYT0QWZ92

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

N/A06429810197207
N/A06429810197214