← Back to catalogue

Fetal monitor

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref FM20510(k) K100885Ref Biocare FM-1

by Bistos Co., Ltd.

Identity

Device Name: Fetal monitor EUDAMED
Model / Reference: FM20 EUDAMED
Biocare FM-1 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800012335020 EUDAMED
08800012330018 EUDAMED
Basic UDI-DI: B-08800012335020 EUDAMED
B-08800012330018 EUDAMED
510(k) Number: K100885 FDA 510(k)
FDA Product Code: HGM FDA 510(k)
EMDN Code: Z12080101 FOETAL MONITORS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.2740 FDA 510(k)
Regulation Number: 884.2740 FDA 510(k)
Market of Registration: Spain EUDAMED
Germany EUDAMED
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Fetal monitor by Bistos Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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

Manufacturer

Manufacturer: Bistos Co., Ltd.
EUDAMED SRN: KR-MF-000035951
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (3)

EUDAMED 5a6f43b1-aeed-431f-ab5f-e94ffd5c5ae2 61 fields · synced Jul 28, 2026
FDA 510(k) K100885 24 fields · synced May 18, 2026
EUDAMED 1545c767-3ae6-4ac6-a3a5-5440ed196a73 61 fields · synced Jul 9, 2026