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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

8010106 — Class IIa MDD by Oxigen Salud, S.A.

MD Atlas
Oxigen Salud, S.A.

EUDAMED last updated this device on Mar 14, 2024

8010106

B-08436542180139

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Oxigen Salud, S.A.
UDI-DI code: 08436542180139
Reference / catalog number: 8010106

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Manufacturer information

Organization name: Oxigen Salud, S.A.
SRN: ES-MF-000036693
Manufacturer status: Active

Critical warnings

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

CW040
EUDAMED did not publish a description for this code.
CW071
EUDAMED did not publish a description for this code.
CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Portugal		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08436542180139
Basic UDI-DI: B-08436542180139
Reference / catalog number: 8010106
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: Gas comprimido envasado en botella a presión de 15 litros.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 15 MU34

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

8010049B-08436542180146On the market 8010099B-08436542180108On the market 8010121B-08436542180184On the market 8010108B-08436542180160On the market 8010080B-08436542180092On 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.