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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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KRYO ICE — 3 UDI-DI variants, MDR (Kaltek S.r.l.)

MD Atlas
Kaltek S.r.l.

Data from EUDAMED, last updated May 31, 2026

KRYO ICE

805551056kryo_ice9H

3 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: Kaltek S.r.l.

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Device characteristics

Active device

Legacy certificates

Certificate number: IT348898
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)
Validity: Jan 13, 2026 → Jan 12, 2030

Identity & classification

Basic UDI-DI: 805551056kryo_ice9H
Device name: —
Device model: KRYO ICE
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Jan 19, 2026

Manufacturer & authorised representative

Manufacturer

Name: Kaltek S.r.l.
SRN: IT-MF-000019573
Country: Italy
Email: info@kaltek.it
Phone: +39 0498703410

Variants by status

UDI-DI variants

3 UDI-DI variants

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Applied filters

basicUdiUlid01KFBHFMYCN0CZQSDKJERF6112

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

Kryo ice08055510560249
381908055510560232
KRYO ICE08055510560256