Statistics for StethoMe

3Total Devices

3Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

2Countries

Certificate health for StethoMe

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for StethoMe

Showing 1–3 of 3 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
-	`-`	`05903839024276`	1	On the market
-	`-`	`05903839024245`	1	On the market
-	`-`	`05903839024221`	1	On the market

Device families (Basic UDI-DI) of StethoMe

Showing 1–3 of 3 device families.

Market presence of StethoMe

Devices placed in 2 countries

Poland2
France1

EUDAMED update: Oct 7, 2024

StethoMe Sp. z o.o.

PL-MF-000025860

Active

Address: Winogrady, 18a 61-663 Poznań
Role: Manufacturer
Date of registration: Jul 8, 2022
Country: PL Poland

About StethoMe

SRN: PL-MF-000025860
Role: Manufacturer
Country: Poland
Organization name: StethoMe Sp. z o.o.
EU VAT number: PL 783 17 26 542
EORI: PL783172654200000
Trade register: 0000558650
Date of registration: Jul 8, 2022

Contact details for StethoMe

Address: 18A, WINOGRADY 61-663 POZNAŃ POLAND
Email: support@stethome.com
Website: https://stethome.com

Validator

Name: Urząd Rejestracji Produktów Leczniczych
SRN: PL-CA-014
Phone: +48 22 492 11 71
Email: wm@urpl.gov.pl

Officers and regulatory representatives of StethoMe

ELBANOWSKI Paweł
Ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the QMS, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the PMS obligations are complied with in accordance with Art. 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investig. devices, the statement referred to in Sec. 4.1 of Ch. II of An.XV is issued.
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