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Organization name
UDI-DI code
Reference / catalog number

c-med° alpha — Class IIa MDR by Cosinuss GmbH

MD Atlas
Cosinuss GmbH

EUDAMED last updated this device on Nov 24, 2023

c-med° alpha

426046302CMED4F

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cosinuss GmbH
UDI-DI code: 04260463020281
Reference / catalog number: 4260463020281

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Manufacturer information

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

Critical warnings

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

CW014
Product with application parts of type BF (Body Floating) - low battery powered supply voltag
CW010
FU Symbol labeled to consult the IFU

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: c-med° alpha
UDI-DI code: 04260463020281
Basic UDI-DI: 426046302CMED4F
Reference / catalog number: 4260463020281
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: Size L
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 12.5 MU50

EMDN nomenclature code(s)

Z12030601COMPLETE VITAL SIGNS TELEMETRY SYSTEMS

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

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Certificates

Certificate health across this manufacturer's portfolio.

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