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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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ComfoCap — 12 UDI-DI variants, MDR (Sooma Oy)

MD Atlas
Sooma Oy

Data from EUDAMED, last updated May 23, 2026

ComfoCap

6430067180002US

12 UDI-DI variants

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

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

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 6430067180002US
Device name: ComfoCap
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Mar 22, 2022

Manufacturer & authorised representative

Manufacturer

Name: Sooma Oy
SRN: FI-MF-000004844
Country: Finland
Email: regulatory@soomamedical.com
Phone: +358 10 328 9811

Variants by status

UDI-DI variants

12 UDI-DI variants

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Applied filters

basicUdiUlid01FS7GREPV161H3CQYQCG9H7ZS

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

CCL006430067180072
CCL206430067180102
CCL306430067180133
CCM006430067180065
CCM206430067180096
CCM306430067180126
CCS006430067180058
CCS206430067180089
CCS306430067180119
CCXS006430067180348
CCXS206430067180355
CCXS306430067180362