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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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Organization name
UDI-DI code
Reference / catalog number

3895 — Class I MDR by Kaltek S.r.l.

MD Atlas
Kaltek S.r.l.

EUDAMED last updated this device on May 29, 2026

3895

805551056kryogelDE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kaltek S.r.l.
UDI-DI code: 08055510560706
Reference / catalog number: 3895

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View device family (Basic UDI)

Manufacturer information

Organization name: Kaltek S.r.l.
SRN: IT-MF-000019573
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

IT348898Issued
Quality management systemNotified body: 1370Expiry: Jan 12, 2030
0425-MDR-030116-00Issued
Quality assuranceNotified body: 0425Expiry: Jan 8, 2030

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08055510560706
Basic UDI-DI: 805551056kryogelDE
Reference / catalog number: 3895
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 20
Additional product description: —
Additional information URL: https://www.kaltek.it/it/prodotti/sanitari/dispositivi-medici-sanitari/ghiaccio-e-accessori/ghiaccio-sintetico-istantaneo
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08055510560706

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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