Question 1

What types of medical devices does Medex International Inc. manufacture?

Accepted Answer

Medex International Inc. produces a variety of Class I medical devices, including single-use and reusable items. Their portfolio covers surgical drapes, gowns, sterile processing supplies, wound care dressings, patient monitoring accessories, and basic diagnostic tools like thermometers and blood pressure cuffs. These devices are designed for clinical, surgical, and home healthcare environments to support infection control, patient care, and diagnostic procedures.

Question 2

Where is Medex International Inc. based, and where are their devices authorised for use?

Accepted Answer

Medex International Inc. is based in the United States. While their headquarters are in the US, their devices are authorised for distribution within the European Economic Area (EEA) under EU medical device regulations. The company’s products are registered in the EUDAMED database, which is the EU’s regulatory transparency system for medical devices.

Question 3

Which regulatory registries list Medex International Inc.’s devices?

Accepted Answer

Medex International Inc.’s devices are listed in the EUDAMED database, which is the official EU registry for medical device information. This registry provides transparency on device authorisations, manufacturers, and other regulatory details within the European Economic Area. No other registries or jurisdictions are specified for this portfolio.

Question 4

How are Medex International Inc.’s devices classified under EU regulations?

Accepted Answer

All of Medex International Inc.’s devices fall under Class I classification in the EU regulatory framework. Class I devices are generally considered low-risk and may require less stringent regulatory oversight compared to higher-risk classes. This classification is based on the intended use and risk profile of the devices, such as surgical drapes, gowns, and basic diagnostic tools.

Question 5

Are Medex International Inc.’s devices authorised for use outside the European Economic Area?

Accepted Answer

The provided information does not specify whether Medex International Inc.’s devices are authorised for use outside the European Economic Area. The company’s devices are registered in EUDAMED and authorised for distribution within the EEA under EU medical device regulations. For other regions, such as the US or other global markets, additional regulatory pathways (e.g., FDA clearance, ISO certifications, or local country requirements) would apply, but these are not detailed in the available data.

Medex International Inc.

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FDA Establishments (1)

Device	Model / Reference	Registries	Class	Status
Medental	PCCS25g15ml	FDA UDI	Class II	Active
Stress Guard, Model Herdev1	K004008	FDA 510(k)	Class II	Active
Blood Tubing Set	K852605	FDA 510(k)	Class II	Active
Medex	3T70	EUDAMED	Class I	Active
Medex	3T55	EUDAMED	Class I	Active
Medex	3S11	EUDAMED	Class I	Active
Medex	4T26	EUDAMED	Class I	Active
Medex	2S15	EUDAMED	Class I	Active
Medex	2T17	EUDAMED	Class I	Active
Medex	3T36	EUDAMED	Class I	Active
Medex	4T25	EUDAMED	Class I	Active
Medex	4S30	EUDAMED	Class I	Active
Medex	3T52	EUDAMED	Class I	Active
Medex	2A10	EUDAMED	Class I	Active
Medex	3T09	EUDAMED	Class I	Active
Medex	4S40	EUDAMED	Class I	Active
Medex	2S16	EUDAMED	Class I	Active
Medex	3T96	EUDAMED	Class I	Active
Medex	3S15	EUDAMED	Class I	Active
Medex	3T31	EUDAMED	Class I	Active
Medex	3T35	EUDAMED	Class I	Active
Medex	4T09	EUDAMED	Class I	Active
Medex	3T11	EUDAMED	Class I	Active
Medex	2A16	EUDAMED	Class I	Active
Medex	3A53	EUDAMED	Class I	Active
Medex	3A20	EUDAMED	Class I	Active
Medex	4S08	EUDAMED	Class I	Active
Prosthetic components for lower limb	2T16	EUDAMED	Class I	Active
Medex	4TC1	EUDAMED	Class I	Active
Medex	2T12	EUDAMED	Class I	Active
Medex	3S60	EUDAMED	Class I	Active
Medex	3T66	EUDAMED	Class I	Active
Medex	3T30	EUDAMED	Class I	Active
Medex	3S53	EUDAMED	Class I	Active
Medex	2A17	EUDAMED	Class I	Active
Medex	4A80	EUDAMED	Class I	Active
Medex	3T95	EUDAMED	Class I	Active
Medex	3T86	EUDAMED	Class I	Active
Medex	3T80	EUDAMED	Class I	Active
Medex	3S10	EUDAMED	Class I	Active
Medex	3T27	EUDAMED	Class I	Active
Medex	3T99	EUDAMED	Class I	Active
Medex	4T28	EUDAMED	Class I	Active
Medex	3T61	EUDAMED	Class I	Active
Medex	3T54	EUDAMED	Class I	Active
Medex	3A23	EUDAMED	Class I	Active
Medex	4A25	EUDAMED	Class I	Active
Medex	2T13	EUDAMED	Class I	Active
Medex	2T22	EUDAMED	Class I	Active
Medex	3T20	EUDAMED	Class I	Active