← Back to catalogue

Cpmx1

FDA UDI

Class U (US FDA UDI)

by Compremium AG

Identity

Trade Name
CPMX1 FDA UDI
Generic Name
Compartmental-pressure monitoring system, reusable FDA UDI
Device Name
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value. FDA UDI
Model / Reference
1 FDA UDI
Description
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value. FDA UDI

Identifiers

Primary DI / UDI-DI
G247CPMX10 FDA UDI
510(k) Number
K223509 FDA UDI
FDA Product Code
LXC FDA UDI
GMDN Term
Compartmental-pressure monitoring system, reusable FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Compartmental-pressure monitoring system, reusable

Cpmx1 by Compremium AG — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Compartmental-pressure monitoring system, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Compremium AG

Sources (1)

  • FDA UDI 8652e20f-4dff-4f51-aaa3-3234714b1f91 36 fields · synced May 30, 2026