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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

BugWatcher — Class I MDR by Pulso ediciones SL

MD Atlas
Pulso ediciones SL

EUDAMED last updated this device on Feb 15, 2022

BugWatcher

84370242238437024223009F2

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Pulso ediciones SL
UDI-DI code: 08437024223009
Reference / catalog number: N/A

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Manufacturer information

Organization name: Pulso ediciones SL
SRN: ES-MF-000015836
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

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

Device identification

Trade name: BugWatcher
UDI-DI code: 08437024223009
Basic UDI-DI: 84370242238437024223009F2
Reference / catalog number: N/A
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: The BugWatcher solution is composed of an ICT platform (website and mobile application) and three screening devices for early detection of superbugs. The three screening devices are: - LumAir LM365 for environmental air monitoring - mVOC detector for human detection by breath analysis - Lateral flow strips for human and fomites detection by sampling gathering
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0299IVD INSTRUMENTS - OTHER

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.