Fetal/Maternal Monitor (BFM-700M)

by Shenzhen Bestman Instrument Co., Ltd.

Ref BFM-700MModel BFM-700/BFM-700+/BFM-700A/BFM-700M/BFM-700E/BFM-700E+

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number69374926BFM06937492600BH Basic UDI-DI 16937492670040UDI-DI	Date13 Jun 2025Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Fetal/Maternal Monitor
Model / Reference: BFM-700/BFM-700+/BFM-700A/BFM-700M/BFM-700E/BFM-700E+, BFM-700M

Primary DI / UDI-DI: 16937492670040
Basic UDI-DI: 69374926BFM06937492600BH
Direct Marketing DI: 16937492670040
EMDN Code: Z1203020201 Multi–parameter patient bedside monitors

Device Class: Class IIa
EU market of registration: Italy

Manufacturer details

EUDAMED SRN: CN-MF-000031725
Authorised representative: Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Bestman Instrument Co., Ltd.

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Class II
Doppler Fetal Heartbeat Rate Detector

Class II
Vascular doppler detector

Class IIa

Properties

Measuring Function

Other properties (12)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Incorporates Medicinal Product: No