Central Monitoring System MFM-CMS

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref MFM-CMSRef FTS-6Ref MFM-CNS Lite

by Edan Instruments, Inc.

Identity

Trade Name: Central Monitoring System EUDAMEDFDA UDI
Generic Name: Obstetrical monitoring/analysis software FDA UDI
Centralized patient monitor FDA UDI
Device Name: Central Monitoring System EUDAMED
Model / Reference: MFM-CMS EUDAMEDFDA UDI
FTS-6 EUDAMED
MFM-CNS Lite EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI: 06944413814264 EUDAMEDFDA UDI
06944413807181 EUDAMED
06944413807983 EUDAMEDFDA UDI
Basic UDI-DI: 69444138MFMCMSTE EUDAMED
69444138FTS6UZ EUDAMED
69444138MFMCNSSYZ EUDAMED
FDA Product Code: HGM FDA UDI
MHX FDA UDI
EMDN Code: Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
GMDN Term: Obstetrical monitoring/analysis software FDA UDI
Centralized patient monitor FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 884.2740 FDA UDI
870.1025 FDA UDI
Special Device Type: Software EUDAMED
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMEDEUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

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

FDA UDIFDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Central Monitoring System MFM-CMS is a Class IIb medical device designed for continuous patient monitoring in clinical settings. It collects and displays vital signs from connected bedside monitors to support clinical decision-making.

This non-sterile, non-reusable system is supplied for use in healthcare facilities and requires appropriate cleaning and maintenance between uses. It is not implantable, does not measure physiological parameters directly, and operates under FDA 510(k) and MDR regulatory authorizations.

Frequently asked questions

Is the Central Monitoring System MFM-CMS sterile?

No, the device is not sterile, as indicated by the STERILE field being set to 0 in the specifications.

Can the Central Monitoring System MFM-CMS be reused?

No, the device is designed for single use only, as shown by the REUSABLE field being 0 and REPROCESSED being 0, indicating it is not intended for reuse or reprocessing.

What regulatory authorizations does the Central Monitoring System MFM-CMS have?

The device has both FDA 510(k) and MDR (Medical Device Regulation) authorizations, as explicitly listed in the AUTHORIZATIONS field.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

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/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K232694	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K143695	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K120727	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K100358	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K171178	Class IIb	Active
EUDAMED	European Union	CE/MDR	69444138MFMCMSTE	Class IIb	Active

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Manufacturer

Manufacturer: Edan Instruments, Inc.
EUDAMED SRN: CN-MF-000009957
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (6)

EUDAMED 25fb10d1-75d5-4736-88a9-8fb0c54a473d 61 fields · synced Sep 18, 2026
EUDAMED 4f596a75-4d42-4f84-adbd-994aaa410f32 61 fields · synced May 18, 2026
FDA UDI fa1500ec-ba73-4616-88b9-77ed0f71cd6e 32 fields · synced May 30, 2026
FDA UDI 32aae3b3-d3be-4511-bbc1-8107e8a084b0 32 fields · synced May 30, 2026
EUDAMED 81c52c7e-e8ef-47bd-b846-2cca2d675449 61 fields · synced Jun 20, 2026
FDA 510(k) K232694 1 fields · synced May 18, 2026