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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

BK_N2_LIQ_GMED — Class IIa MDR by S.E. Carburos…

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

EUDAMED last updated this device on Feb 4, 2025

BK_N2_LIQ_GMED

8420219LINBULKWA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: S.E. Carburos Metálicos, S.A.
UDI-DI code: 08420219200107
Reference / catalog number: BK_N2_LIQ_GMED

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Manufacturer information

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

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Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW132
EUDAMED did not publish a description for this code.
CW268
EUDAMED did not publish a description for this code.
CW072
EUDAMED did not publish a description for this code.
CW999
En caso de contacto con los ojos, enjuague los ojos inmediatamente y a fondo con agua durante al menos 15 minutos. En caso de congelación, rocíe con agua durante al menos 15 minutos. En todos los casos, consulte a su médico. Para obtener más información de seguridad, solicite la hoja de datos de seguridad

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Oct 1, 2024	Still on market
Portugal	Oct 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08420219200107
Basic UDI-DI: 8420219LINBULKWA
Reference / catalog number: BK_N2_LIQ_GMED
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Nitrogênio líquido a granel para criopreservação e crioterapia é um gás liquefeito armazenado em recipientes criogênicos
Additional information URL: https://www.carburosmedica.com/productos/sanitarios.php
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0902CLINICAL/THERAPEUTIC APPLICATIONS LIQUID NITROGEN

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

Certificates

Certificate health across this manufacturer's portfolio.

ES24/00000069Issued
Quality management systemNotified body: 1639Expiry: Jan 9, 2029
ES/00000039Issued
Quality management systemNotified body: 1639Expiry: Jan 9, 2029