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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

OXYWISE — Class IIb MDD by OXYWISE, s.r.o.

MD Atlas
OXYWISE, s.r.o.

EUDAMED last updated this device on May 21, 2026

OXYWISE

B-08588009198321

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OXYWISE, s.r.o.
UDI-DI code: 08588009198321
Reference / catalog number: O3150

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View device family (Basic UDI)

Manufacturer information

Organization name: OXYWISE, s.r.o.
SRN: SK-MF-000034288
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW273
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement	Jun 15, 2017	Still on market

Device identification

Trade name: OXYWISE
UDI-DI code: 08588009198321
Basic UDI-DI: B-08588009198321
Reference / catalog number: O3150
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: Medical oxygen generator is an oxygen-generating (concentrating) machine. The separation is accomplished with a molecular sieve inside two vessels and set of pneumatic valves. To inlet air flows, from outlet oxygen flows. Other gases flow as exhaust gas through the exhaust.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08588009198321

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

R9099RESPIRATORY AND ANAESTHESIA DEVICES - 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

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Related devices

OXYWISEB-08588009198277On the market OXYWISEB-08588009198291On the market OXYWISEB-08588009198307On the market OXYWISEB-08588009198314On the market OXYWISE085880091980MEDGENEBOn 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.