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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

EVOLUTION CSHP14 Supine Head… — Class I MDR

MD Atlas
VascoCare Medical Limited

EUDAMED last updated this device on Feb 3, 2022

EVOLUTION CSHP14 Supine Head Positioner, Large Style 1 Disposable Cover

539153592009EL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VascoCare Medical Limited
UDI-DI code: 05391535920099
Reference / catalog number: CSHP14

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Manufacturer information

Organization name: VascoCare Medical Limited
SRN: IE-MF-000004444
Manufacturer status: Active

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.

Critical warnings

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

CW010
Internationally recognized symbol for Consult Instructions For Use.

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement	Apr 1, 2020	Still on market
Germany	Apr 1, 2020	Still on market

Device identification

Trade name: EVOLUTION CSHP14 Supine Head Positioner, Large Style 1 Disposable Cover
UDI-DI code: 05391535920099
Basic UDI-DI: 539153592009EL
Reference / catalog number: CSHP14
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: http://www.vascocare.com/original-positioner-gallery.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V080302PATIENT POSITIONING MEDICAL CUSHIONS

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

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