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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

RespiraSense — Class IIa MDR by PMD Device Solutions Ltd

MD Atlas
PMD Device Solutions Ltd

EUDAMED last updated this device on Jun 26, 2024

RespiraSense

53915332900RespirasenseDK

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PMD Device Solutions Ltd
UDI-DI code: 05391533290002
Reference / catalog number: RSV4

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Manufacturer information

Organization name: PMD Device Solutions Ltd
SRN: IE-MF-000016708
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 Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement	Jun 2, 2017	Still on market

Device identification

Trade name: RespiraSense
UDI-DI code: 05391533290002
Basic UDI-DI: 53915332900RespirasenseDK
Reference / catalog number: RSV4
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: 6 Lobe Kit box
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0380DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES

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

RespiraSense53915332900RespirasenseDKOn the market RespiraSense53915332900RespirasenseDKOn the market RespiraSenseB-IE-MF-000016708PGOn the market RespiraSense App53915332900RespirasenseDKOn 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.