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Organization name
UDI-DI code
Reference / catalog number

4260463020243 — Class IIa MDR by Cosinuss GmbH

MD Atlas
Cosinuss GmbH

EUDAMED last updated this device on Feb 3, 2023

4260463020243

426046302CMEDAPP4R

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cosinuss GmbH
UDI-DI code: 04260463020243
Reference / catalog number: 4260463020243

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Manufacturer information

Organization name: Cosinuss GmbH
SRN: DE-MF-000006937
Manufacturer status: Active

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: 04260463020243
Basic UDI-DI: 426046302CMEDAPP4R
Reference / catalog number: 4260463020243
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: iOS App To be used with c-med° alpha sensor (Basic UDI-DI:426046302CMED4F )
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12030692VITAL SIGNS TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

4260463020359426046302CMED4FOn the market c-med alpha Set426046302CMED4FOn the market 4260463020366426046302CMED4FOn the market c-med alpha Set426046302CMED4FOn the market 4260463020328426046302CMED4FOn the market

Certificates

Certificate health across this manufacturer's portfolio.

G10 101625 0003Issued
Quality management systemNotified body: 0123Expiry: Feb 1, 2028