Question 1

What types of medical devices does PAR Medizintechnik GmbH & Co. Kommanditgesellschaft manufacture?

Accepted Answer

PAR Medizintechnik specializes in blood pressure cuffs, offering both reusable and single-use options. These cuffs are designed specifically for digital blood pressure monitoring devices and come in various adult sizes, including extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL). Examples include the TONOPORT BP Single-Use Cuffs for adults, which are tailored for precise measurements.

Question 2

Where is PAR Medizintechnik GmbH & Co. Kommanditgesellschaft based?

Accepted Answer

The company is based in the United States. As a manufacturer, it operates within the U.S. regulatory framework, ensuring its blood pressure cuffs comply with applicable standards for medical devices.

Question 3

In which regulatory registries or databases are PAR Medizintechnik’s devices listed?

Accepted Answer

PAR Medizintechnik’s blood pressure cuffs are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Question 4

How are PAR Medizintechnik’s blood pressure cuffs classified under U.S. regulations?

Accepted Answer

The company’s blood pressure cuffs are classified as Class II medical devices under FDA regulations. This classification is based on their intended use and risk level, requiring compliance with specific controls to ensure safety and effectiveness while allowing for streamlined regulatory oversight compared to higher-risk devices.

Device	Model / Reference	Registries	Class	Status
blood pressure cuff, Size XS, for digital devices	A2534-xs	FDA UDI	Class II	Active
blood pressure cuff, Size M, for digital devices	A2534-m	FDA UDI	Class II	Active
TONOPORT BP Single-Use Cuff for Adults, Standard	2001589-233	FDA UDI	Class II	Active
Tonoport Bp Cuff Adult Small	2001589-211	FDA UDI	Class II	Active
blood pressure cuff, Size L, for digital devices	A2534-l	FDA UDI	Class II	Active
Tonoport Bp Cuff Adult Standard	2001589-212	FDA UDI	Class II	Active
TONOPORT BP Cuff for Adults, Extra-large	2001589-214	FDA UDI	Class II	Active
TONOPORT BP Single-Use Cuff for Adults, Small	2001589-232	FDA UDI	Class II	Active
blood pressure cuff, Size XXL, for digital devices	A2534-xxl	FDA UDI	Class II	Active
Tonoport Bp Cuff Adult Large	2001589-213	FDA UDI	Class II	Active
blood pressure cuff, Size XL, for digital devices	A2534-xl	FDA UDI	Class II	Active
TONOPORT BP Single-Use Cuff for Adults, Extra-large	2001589-235	FDA UDI	Class II	Active
TONOPORT BP Cuff for Adults, Standard	2001589-212	FDA UDI	Class II	Active
TONOPORT BP Cuff for Adults, Small	2001589-211	FDA UDI	Class II	Active
blood pressure cuff, Size S, for digital devices	A2534-s	FDA UDI	Class II	Active
TONOPORT BP Cuff for Adults, Large	2001589-213	FDA UDI	Class II	Active
Tonoport Bp Cuff Adult Extra Large	2001589-214	FDA UDI	Class II	Active
TONOPORT BP Single-Use Cuff for Adults, Large	2001589-234	FDA UDI	Class II	Active

PAR Medizintechnik GmbH & Co. Kommanditgesellschaft

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