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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

myPatientSpace — Class I MDD by myPatientSpace Limited

MD Atlas
myPatientSpace Limited

EUDAMED last updated this device on Jun 27, 2024

myPatientSpace

B-53915473600010

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: myPatientSpace Limited
UDI-DI code: 53915473600010
Reference / catalog number: 1

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Manufacturer information

Organization name: myPatientSpace Limited
SRN: IE-MF-000042319
Manufacturer status: Active

Market distribution

Primary placement in Ireland; available across 1 country total.

Placed on the market in Ireland; per-country availability dates not published.

Device identification

Trade name: myPatientSpace
UDI-DI code: 53915473600010
Basic UDI-DI: B-53915473600010
Reference / catalog number: 1
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

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

EMDN nomenclature code(s)

W020106019082VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES
C019004CARDIOVASCULAR MONITORING SYSTEMS
J010701PULMONARY BLOOD PRESSURE REMOTE MONITORING SYSTEMS (INCLUDING SENSORS)
V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

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

This device is not currently linked to any other device.

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.