Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

RespiraSense — Class IIb MDD by PMD Device Solutions Ltd

MD Atlas
PMD Device Solutions Ltd

EUDAMED last updated this device on May 16, 2024

RespiraSense

B-IE-MF-000016708PG

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PMD Device Solutions Ltd
UDI-DI code: D-IE-MF-000016708PG
Reference / catalog number: N/A

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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.

CW011
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	Jan 1, 2028

Device identification

Trade name: RespiraSense
UDI-DI code: D-IE-MF-000016708PG
Basic UDI-DI: B-IE-MF-000016708PG
Reference / catalog number: N/A
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: RespiraSense patient respiratory monitor system
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 RespiraSense53915332900RespirasenseDKOn 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.