EUDAMED update: May 4, 2026

Cook Incorporated

US-MF-000003180

Active1,212 devices

Address: 750 Daniels way, 47404 Bloomington
Role: Manufacturer
Date of registration: Apr 19, 2021
Country: United States

Cook Incorporated is a medical device manufacturer registered in EUDAMED. The company has 1,269 devices on the EU market across 32 countries. Headquartered in Bloomington, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Cook Inc.

: US-MF-000003180
Role: Manufacturer
Country: United States
Organization name: Cook Incorporated
EU VAT number: Not applicable
EORI: N/A
Trade register: 1820334 - FDA Registration Number
Date of registration: Apr 19, 2021

Contact details for Cook Inc.

Phone: +1 812 339 2235
Email: Regsubmissions@CookMedical.com
Website: https://www.cookmedical.com/
Address: 750 DANIELS WAY 47404 BLOOMINGTON UNITED STATES

Competent authority

Name: Health Products Regulatory Authority, Medical Devices Department

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

Officers and regulatory representatives of Cook Inc.

SANTNER Aaron
- The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
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GRAF Matt
The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; - The reporting obligations referred to in Articles 87 to 91 of the EU MDR are fulfilled. Ensuring Cook Inc.’s post-market surveillance system is set up, implemented, and maintained. Reporting obligations regarding serious incidents, field safety corrective actions, trend reporting, and vigilance data.
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Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Integral Filiform Urethral Dilator	Integral Filiform Urethral Dilator	`FFD-180032`	`00827002179097`	1	On the market
Percutaneous Access Set With Hydrophilic Coating	Percutaneous Access Set With Hydrophilic Coating	`NPAS-100-RH`	`00827002104600`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-8`	`00827002266070`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-2-4`	`00827002266223`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-3`	`00827002260931`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-2.5-4`	`00827002264045`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-12`	`00827002260993`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-3`	`00827002261099`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-3-8`	`00827002267107`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-4`	`00827002260948`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-6`	`00827002266063`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-1.5-4`	`00827002266148`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-6`	`00827002261112`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-12`	`00827002261150`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-2`	`00827002261075`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-2`	`00827002261006`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-1.5-4`	`00827002260917`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-8`	`00827002260962`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-3-12`	`00827002267244`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-4`	`00827002266056`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-1.5-2`	`00827002266117`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-3`	`00827002261013`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-2-2`	`00827002261198`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-2-12`	`00827002266414`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-6`	`00827002261037`	1	On the market

Product	Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Integral Filiform Urethral Dilator	Integral Filiform Urethral Dilator	`FFD-180032`	`00827002179097`	1	On the market
Percutaneous Access Set With Hydrophilic Coating	Percutaneous Access Set With Hydrophilic Coating	`NPAS-100-RH`	`00827002104600`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-8`	`00827002266070`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-2-4`	`00827002266223`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-3`	`00827002260931`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-2.5-4`	`00827002264045`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-12`	`00827002260993`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-3`	`00827002261099`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-3-8`	`00827002267107`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-4`	`00827002260948`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-6`	`00827002266063`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-1.5-4`	`00827002266148`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-6`	`00827002261112`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-12`	`00827002261150`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-3-2`	`00827002261075`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-2`	`00827002261006`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-1.5-4`	`00827002260917`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2-8`	`00827002260962`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-3-12`	`00827002267244`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-3-4`	`00827002266056`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-1.5-2`	`00827002266117`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-3`	`00827002261013`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-90-2-2`	`00827002261198`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-150-2-12`	`00827002266414`	1	On the market
Advance Micro® 14	Advance Micro® 14	`PTA3-14-50-2.5-6`	`00827002261037`	1	On the market

Cook Incorporated

About Cook Inc.

Contact details for Cook Inc.

Competent authority

Officers and regulatory representatives of Cook Inc.

Related searches

About Cook Inc.

Contact details for Cook Inc.

Competent authority

Officers and regulatory representatives of Cook Inc.

Approved members

Statistics for Cook Inc.

Certificate health for Cook Inc.

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Device catalog for Cook Inc.

Device families (Basic UDI-DI) of Cook Inc.

Market presence of Cook Inc.

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Authorised representatives

Related searches

Certificate health for Cook Inc.

Statistics for Cook Inc.

Market presence of Cook Inc.

Devices by risk class

Approved members

Related documents

Connected operators

Importers

Authorised representatives

Device catalog for Cook Inc.

Device families (Basic UDI-DI) of Cook Inc.