Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

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

MD Atlas
Koite Health Oy

Data from EUDAMED, last updated May 23, 2026

Lumoral Clinic

6429810197LumoralClini66

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

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

Active device

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: 6429810197LumoralClini66
Device name: Lumoral Clinic
Device model: 03, 13
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

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01J1W8RNS7AQ1YJ0XK16SY1MQ1

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

03, 1306429810197184
0306429810197252