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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

600027 — Class IIb MDR by Optima Medical Swiss AG

MD Atlas
Optima Medical Swiss AG

EUDAMED last updated this device on Jul 26, 2024

600027

42607257600900MR

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Optima Medical Swiss AG
UDI-DI code: 04260725760542
Reference / catalog number: 600027

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Manufacturer information

Organization name: Optima Medical Swiss AG
SRN: CH-MF-000041543
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260725760542
Basic UDI-DI: 42607257600900MR
Reference / catalog number: 600027
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Inhalation
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R0699NEBULISATION AND HUMIDIFICATION SYSTEMS - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

60007442607257600600MAOn the market 60011742607257600600MAOn the market 60011942607257600600MAOn the market 60003642607257600700MFOn the market 60012142607257600600MAOn 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.