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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

06501010 — Class IIa MDD by Przedsiębiorstwo…

MD Atlas
Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.

EUDAMED last updated this device on Aug 12, 2024

06501010

B-05904507650346

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
UDI-DI code: 05904507650346
Reference / catalog number: 06501010

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View device family (Basic UDI)

Manufacturer information

Organization name: Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
SRN: PL-MF-000038261
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Nov 7, 2011	Aug 12, 2025

Device identification

Trade name: not provided
UDI-DI code: 05904507650346
Basic UDI-DI: B-05904507650346
Reference / catalog number: 06501010
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Przeznaczony do przeprowadzenia zabiegów krioterapii miejscowej, przy użyciu par zimnego azotu. Krioterapia miejscowa polega na schładzaniu fragmentów ciała w celu wywołania zmian w obrębie tkanek, w których obniżono temperaturę.
Additional information URL: https://sklep.technomex.pl/froozer-urzadzenie-do-krioterapii-p-179.html
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Expiration date
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Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05904507650346

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EMDN nomenclature code(s)

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

Z129099VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER

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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