MY01 Continuous Compartmental Pressure Monitor

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref MY01-0001

by MY01 Inc.

Identity

Trade Name: MY01 Continuous Compartmental Pressure Monitor EUDAMEDFDA UDI
Generic Name: Compartmental-pressure monitoring system, single-use FDA UDI
Device Name: MY01 Continuous Compartmental Pressure Monitor EUDAMED
Model / Reference: MY01-0001 EUDAMED
0001 FDA UDI

Identifiers

Catalog Number: MY01-0001 FDA UDI
Primary DI / UDI-DI: 07540162030017 EUDAMEDFDA UDI
Basic UDI-DI: B-07540162030017 EUDAMED
754016203000000000002SC EUDAMED
FDA Product Code: LXC FDA UDI
EMDN Code: Z12039002 INTRA COMPARTMENTAL PRESSURE MONITOR SYSTEMS EUDAMED
GMDN Term: Compartmental-pressure monitoring system, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
U FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

The MY01 Continuous Compartmental Pressure Monitor is a medical device designed for the continuous monitoring of compartmental pressure. It is identified by model number MY01-0001 and is manufactured by MY01 Inc.

This device is supplied sterile and is intended for single-use, as it is not designed to be reused or reprocessed. It is classified as a Class IIa device and holds authorizations including FDA 510(k), MDD, and MDR. The device does not contain latex and is not implantable.

Frequently asked questions

Is the MY01 Continuous Compartmental Pressure Monitor reusable?

No, the device is not reusable. It is designed for single-use only and should not be reprocessed after its initial application.

What is the model number for this pressure monitor?

The specific model number for this device is MY01-0001.

Does the MY01 monitor contain latex?

No, the MY01 Continuous Compartmental Pressure Monitor is manufactured without the use of latex.

Is this device supplied in a sterile state?

Yes, the device is supplied sterile to ensure it meets the necessary requirements for clinical use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MY01 – Continuous Perfusion Sensing Technology, Novel digital continuous sensor for monitoring of compartment ..., MY01 Continuous Compartment Pressure Monitor - LEDA, MY01 Continuous Compartmental Pressure Monitor - MEARIS, MY01 Inc. Receives FDA Clearance for the MY01 Continuous ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-07540162030017	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K242997	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K193321	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K210525	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K220952	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K251900	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K202635	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-07540162030017	Class IIa	Active

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Manufacturer

Manufacturer: MY01 Inc.
EUDAMED SRN: CA-MF-000002178
Authorised Representative: CEpartner4U NL-AR-000000111

Sources (4)

EUDAMED c74381e1-857a-43d2-98c1-fa6516da5cca 61 fields · synced Oct 6, 2026
EUDAMED 928ee5d9-35be-4b9c-88ff-d46039dcd03a 61 fields · synced May 19, 2026
FDA UDI e3373bd9-6b9b-4900-bd15-79894378309f 33 fields · synced May 30, 2026
FDA 510(k) K242997 1 fields · synced May 18, 2026