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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

2 HIGH PRESSURE FLEXIBLE… — Class IIb MDD by S.E. Carburos…

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

EUDAMED last updated this device on Aug 4, 2022

2 HIGH PRESSURE FLEXIBLE CONNECTIONS - O2/HE

B-08420219351205

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: 08420219351205
Reference / catalog number: 165002

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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

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Aug 1, 2013	Still on market
Portugal	Aug 1, 2013	Still on market

Device identification

Trade name: 2 HIGH PRESSURE FLEXIBLE CONNECTIONS - O2/HE
UDI-DI code: 08420219351205
Basic UDI-DI: B-08420219351205
Reference / catalog number: 165002
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z120309MEDICAL/MEDICINAL GAS PIPELINE SYSTEMS AND RELATED ACCESSORIES

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