EUDAMED update: Feb 18, 2026

Welch Allyn, Inc.

US-MF-000013394

Active887 devices

Address: State Street Road, 4341 13153 Skaneateles Falls
Role: Manufacturer
Date of registration: Sep 20, 2021
Country: United States

Welch Allyn, Inc. is a medical device manufacturer registered in EUDAMED. The company has 887 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Skaneateles Falls, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Welch Allyn, Inc.

: US-MF-000013394
Role: Manufacturer
Country: United States
Organization name: Welch Allyn, Inc.
EU VAT number: Not applicable
EORI: No EORI Number
Trade register: 1316463
Date of registration: Sep 20, 2021

Contact details for Welch Allyn, Inc.

Phone: +1 814 999 4329
Email: joseph_olsavsky@baxter.com
Website: www.baxter.com
Address: 4341, STATE STREET ROAD 13153 SKANEATELES FALLS UNITED STATES

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Competent authority

Name: Health Products Regulatory Authority, Medical Devices Department

Phone: +353 1 676 4971
Email: devices@hpra.ie

Officers and regulatory representatives of Welch Allyn, Inc.

ROBERT Shawnee
(1) ensuring conformity of the device is appropriately checked in accordance with the Quality Management System (QMS) before the device is released, (2) ensuring Post-Market Surveillance (PMS) obligations are met per Article 10 (10) of the EU MDR, (3) ensuring reporting obligations relating to vigilance are met (ref. Article 87 to 91 of the EU MDR)
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OLSAVSKY Joseph
(1) ensuring technical documentation and EU Declaration of Conformity (DoC) are drawn up and kept up to date; (2) ensuring that the Declaration for investigational device(s) used in clinical trials conforms to General Safety and Performance Requirements (GSPR) apart from aspects covered by the clinical investigation and every precaution has been taken to protect the health and safety of the subject (ref. Annex XV Chapter II Section 4.1 of the EU MDR)
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Connected operators

Importers

6 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
AM12	AM12	`41000-032-53`	`00812345029659`	1	On the market
AM12	AM12	`41000-032-51`	`00732094272109`	1	On the market
AM12	AM12	`41000-032-50`	`00812345021769`	1	On the market
AM12	AM12	`41000-032-55`	`00732094272093`	1	On the market
AM12	AM12	`9293-048-65`	`00817655023137`	1	On the market
AM12	AM12	`9293-048-54`	`00812345029680`	1	On the market
AM12	AM12	`9293-048-55`	`00732094328950`	1	On the market
AM12Q	AM12Q	`9293-062-50`	`00812345029697`	1	On the market
AM15E	AM15E	`9293-063-50`	`00812345029703`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-125`	`00732094325324`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-100`	`00732094325317`	1	On the market
Braun Thermoscan	Braun Thermoscan	`104894`	`00732094325089`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-150`	`00732094325331`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721361`	`00732094192506`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721328`	`00732094191844`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`719653`	`00732094199352`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`715992`	`00732094119985`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`719654`	`00732094213492`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721360`	`00732094192513`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721329`	`00732094192520`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`714730`	`00732094121384`	1	On the market
ECG MULTIFUNCTION ELECTRODE ADAPTOR	ECG MULTIFUNCTION ELECTRODE ADAPTOR	`715006`	`00732094120998`	1	On the market
FlexiPort	FlexiPort	`REUSE-11L-1MQ`	`00732094067040`	1	On the market
FlexiPort	FlexiPort	`VINYL-09-1MQ`	`00732094187458`	1	On the market
FlexiPort	FlexiPort	`REUSE-13-2TP`	`00732094065428`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
AM12	AM12	`41000-032-53`	`00812345029659`	1	On the market
AM12	AM12	`41000-032-51`	`00732094272109`	1	On the market
AM12	AM12	`41000-032-50`	`00812345021769`	1	On the market
AM12	AM12	`41000-032-55`	`00732094272093`	1	On the market
AM12	AM12	`9293-048-65`	`00817655023137`	1	On the market
AM12	AM12	`9293-048-54`	`00812345029680`	1	On the market
AM12	AM12	`9293-048-55`	`00732094328950`	1	On the market
AM12Q	AM12Q	`9293-062-50`	`00812345029697`	1	On the market
AM15E	AM15E	`9293-063-50`	`00812345029703`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-125`	`00732094325324`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-100`	`00732094325317`	1	On the market
Braun Thermoscan	Braun Thermoscan	`104894`	`00732094325089`	1	On the market
Braun Thermoscan	Braun Thermoscan	`06000-150`	`00732094325331`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721361`	`00732094192506`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721328`	`00732094191844`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`719653`	`00732094199352`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`715992`	`00732094119985`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`719654`	`00732094213492`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721360`	`00732094192513`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`721329`	`00732094192520`	1	On the market
ECG Accessory Cardiopulmonary	ECG Accessory Cardiopulmonary	`714730`	`00732094121384`	1	On the market
ECG MULTIFUNCTION ELECTRODE ADAPTOR	ECG MULTIFUNCTION ELECTRODE ADAPTOR	`715006`	`00732094120998`	1	On the market
FlexiPort	FlexiPort	`REUSE-11L-1MQ`	`00732094067040`	1	On the market
FlexiPort	FlexiPort	`VINYL-09-1MQ`	`00732094187458`	1	On the market
FlexiPort	FlexiPort	`REUSE-13-2TP`	`00732094065428`	1	On the market

Welch Allyn, Inc.

About Welch Allyn, Inc.

Contact details for Welch Allyn, Inc.

Export the 887 devices of Welch Allyn, Inc.

Competent authority

Officers and regulatory representatives of Welch Allyn, Inc.

Connected operators

Importers

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About Welch Allyn, Inc.

Contact details for Welch Allyn, Inc.

Export the 887 devices of Welch Allyn, Inc.

Competent authority

Officers and regulatory representatives of Welch Allyn, Inc.

Statistics for Welch Allyn, Inc.

Certificate health for Welch Allyn, Inc.

Related documents

Devices by risk class

Market presence of Welch Allyn, Inc.

Device catalog for Welch Allyn, Inc.

Device families (Basic UDI-DI) of Welch Allyn, Inc.

Connected operators

Importers

Related searches

Certificate health for Welch Allyn, Inc.

Related documents

Statistics for Welch Allyn, Inc.

Market presence of Welch Allyn, Inc.

Devices by risk class

Device families (Basic UDI-DI) of Welch Allyn, Inc.

Device catalog for Welch Allyn, Inc.