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Bistos Co., Ltd.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000035951 FEI 3006179052

Devices
52
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Obelis S.A.BE

What Bistos Co., Ltd. makes

Bistos Co., Ltd. manufactures electric breast pumps, including double-pump models designed for infant feeding support, as well as foetal Doppler systems and their associated probes for prenatal monitoring. The company also produces overhead and head-worn infant phototherapy units for the treatment of neonatal jaundice, including devices like the BiliTouch™ system.

The portfolio includes devices classified as Class I, Class II, Class IIa, and Class IIb under global regulatory frameworks. These products are listed in eudamed, FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in South Korea.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue52

Newest first, rows 1-50 of 52

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  • Fetal monitor Ref BT-380

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Bt-1000

    Active Regimes: 510(k) Registry: GUDID Class:II

  • BT-1000 electrode

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi bebe super Ref BT-150B

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • Cart

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-220l

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-350l

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-300

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-200T

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-410F

    Listed Registry: GUDID Class:I

  • Hi bebe super BT-150L

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-400

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-410A

    Listed Registry: GUDID Class:I

  • Bt-350E

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi-bebe BT-200S

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi bebe super BT-150S

    Active Regimes: 510(k) Registry: GUDID Class:II

  • BiliTouchTM Motif Phototherapy Blanket

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi bebe plus BT-100

    Active Regimes: CE MDD 510(k) Registry: GUDID Class:II

  • Hi-bebe BT-200L

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Duo Double Electric Breast Pump MD-20.2

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Infant Phototherapy Equipment BT-450

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Bt-500

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi-bebe BT-200C

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Hi-dop BT-200V

    Active Regimes: CE MDD 510(k) Registry: GUDID Class:II

  • Bt-220C

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Duo Double Electric Breast Pump AAA0021

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Head-worn light Ref BT-410A

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Infant Phototherapy Equipment Ref K210289

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bt-1000 Ref K232991

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi bebe super (Models BT-150S and BT-150L) Ref K200675

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bt-200V Vascular Doppler Ref K121267

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fetal Monitor, Models Bt-300 And Bt-200 Ref K052190

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Model BT-220L and BT-220C Ref K142799

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hi bebe super (BT-150B) Ref K251512

    Active Regimes: CE MDD 510(k) Registry: 510(k) Class:II

  • Fetal monitor Ref BT-350

    Active Regimes: CE MDD 510(k) Registry: EUDAMED Class:IIa

  • Patient Monitor Ref BT-720

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Gateway Ref BT-710

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Head-worn light Ref BT-410F

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:I

  • Hi-bebe S Ref BT-220C

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Neonatal Phototherapy Unit Ref BT-400

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Fetal monitor Ref BT-300

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Fetal monitor Ref FM20

    Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k) Class:IIa

  • Infant warmer Ref BT-550

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Patient Monitor Ref BT-740

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

  • Hi-dop Ref BT-200V

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Hi-bebe Ref BT-200T

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Hi bebe plus Ref BT-100

    Active Regimes: CE MDD 510(k) Registry: EUDAMED Class:IIa

  • Infant incubator Ref BT-500

    Active Regimes: CE MDD 510(k) Registry: EUDAMED Class:IIb

  • Ultrasound Doppler system with Probes Ref BT-250

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa

  • Patient Monitor Ref BT-780

    Active Regimes: CE MDD Registry: EUDAMED Class:IIb

Rows 1-50 of 52

Showing 1-50 of 52

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
KR-MF-000035951
FDA FEI number
3006179052
DUNS number
689908411
EU VAT number
1208625954
EUDAMED status
Active
EUDAMED registered name
Bistos Co., Ltd.
Registered address
5F and 1502ho, Building D, Gwacheon Pentaone, 117, Gwacheon-daero 12-gil, Gwacheon-si, 13824, Gyeonggi-do, South Korea
Phone
+82 31 750 0340
PRRC contact
Taijun Kang(public in EUDAMED)

Frequently asked questions

How many devices does Bistos Co., Ltd. have in the registry?

The registry currently lists 52 devices for Bistos Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bistos Co., Ltd.'s devices?

Among its 50 most recently registered devices, Bistos Co., Ltd. has devices listed in EUDAMED (19 devices), FDA 510(k) (8 devices) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Bistos Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Bistos Co., Ltd.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Bistos Co., Ltd. in the registry?

The most recently registered devices listed for Bistos Co., Ltd. include Fetal monitor, BT-1000, BT-1000 electrode and Hi bebe super.

Generated automatically from registry data and not verified by a human reviewer.