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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

- — Class IIa MDD by SPAWMET Spółka z o.o.

MD Atlas
SPAWMET Spółka z o.o.

EUDAMED last updated this device on May 28, 2026

-

B-59049170282096

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SPAWMET Spółka z o.o.
UDI-DI code: 59049170282096
Reference / catalog number: -

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View device family (Basic UDI)

Manufacturer information

Organization name: SPAWMET Spółka z o.o.
SRN: PL-MF-000018771
Manufacturer status: Active

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW071
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 59049170282096
Basic UDI-DI: B-59049170282096
Reference / catalog number: -
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: KRIOTEROS Dwutlenek węgla medyczny do krioterapii/kriochirurgii. Gaz skroplony w pojemniku ciśnieniowym z kapilarą, stosowany jako źródło zimna w krioterapii i kriochirurgii. Wyrób medyczny stosowany jako źródło zimna w krioterapii i kriochirurgii, służy do obniżenia temperatury ciała do – 76oC w krioterapii lub lokalnej analgezji poprzez zastosowanie zewnętrzne na powierzchni skóry.
Additional information URL: No additional information URL provided by the manufacturer.
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)59049170282096

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EMDN nomenclature code(s)

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

V0901CLINICAL/THERAPEUTIC APPLICATIONS CARBON DIOXIDE

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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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.