Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Bulk liquid nitrogen — Class IIa MDD by S.E. Carburos…

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

EUDAMED last updated this device on Sep 26, 2022

Bulk liquid nitrogen

B-08420219200107

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: S.E. Carburos Metálicos, S.A.
UDI-DI code: 08420219200107
Reference / catalog number: LINBULK

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

2 HIGH PRESSURE FLEXIBLE CONNECTIONS - AIRB-08420219351236On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2-800, CO2B-08420219351267On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2OB-08420219351250On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - N2O / REPLACEMENTB-08420219351229On the market 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - O2B-08420219351212On the market

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

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

CW086
No inhalar
CW132
Para cualquier información complementaria solicitar la ficha de datos de seguridad
CW416
En caso de que haya contacto con piel y ojos, limpiar inmediatamente los ojos con abundante agua durante al menos15 minutos.
CW010
La cryocirurgía está contraindicada en pacientes con urticaria inducida por frio, crioglobulinemia, criofibrinogenemia y enfermedad de Raynaud. La criocirugía dermatológica puede causar un dolor local pasajero, un edema, una hipopigmentación y una cicatrización retardada.
CW404
En caso de fuga dentro de un área confinada puede haber riesgo de asfixia a concentraciones elevadas (pérdida de conocimiento)
CW203
En caso de fuga dentro de un área confinada puede haber riesgo de asfixia a concentraciones elevadas (pérdida de conocimiento)
CW184
En caso de fuga dentro de un área confinada puede haber riesgo de asfixia a concentraciones elevadas (pérdida de conocimiento)
CW164
Los trasvases y la aplicación del producto deben llevarse a cabo en salas bien ventiladas.
CW081
El contacto con el producto puede causar quemaduras por frío o congelación. En caso de congelación rociar con agua durante al menos 15 minutos.
CW011
En todos los casos consulte a su médico.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Nov 30, 2007	Still on market
Portugal	Nov 30, 2007	Still on market

Device identification

Trade name: Bulk liquid nitrogen
UDI-DI code: 08420219200107
Basic UDI-DI: B-08420219200107
Reference / catalog number: LINBULK
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: Liquid nitrogen in bulk for cryopreservation and cryotherapy. Liquefied gas in cryogenic conditions stored in cryogenic containers.
Additional information URL: No additional information URL provided by the manufacturer.
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