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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

ARGON — Class IIb MDD by S.E. Carburos…

MD Atlas
S.E. Carburos Metálicos, S.A.

EUDAMED last updated this device on Sep 22, 2022

ARGON

B-08420219100094

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: S.E. Carburos Metálicos, S.A.
UDI-DI code: 08420219100094
Reference / catalog number: ARGON

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Manufacturer information

Organization name: S.E. Carburos Metálicos, S.A.
SRN: ES-MF-000003117
Manufacturer status: Active

Critical warnings

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

CW086
No inhalar.
CW203
En caso de fuga en un ambiente confinado puede haber riesgo de asfixia a altas concentraciones.
CW184
En caso de fuga en un ambiente confinado puede haber riesgo de asfixia a altas concentraciones.
CW011
En caso de producirse extravasación accidental de argón en circunstancias especiales, se puede producir embolia gaseosa.
CW132
Para más información consulte la ficha de datos de seguridad.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Sep 22, 2010	Still on market
Portugal	Jun 28, 2018	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08420219100094
Basic UDI-DI: B-08420219100094
Reference / catalog number: ARGON
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Garrafa de alumínio ou aço com válvula padrão
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

K020499DEVICES FOR SURGERY WITH ARGON GAS GENERATOR, SINGLE-USE - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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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.