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Bistos Co., Ltd

www.bistos.co.kr

✓ Record-verifiedregistrations found in 12 marketsEU SRN KR-MF-000035951

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 12 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

17UDI-DI device records

Class I 2Class IIa 8Class IIb 7

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 13 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 2Class IIa 5Class IIb 2

BRBrazilANVISA

5registered devices

Class I 1Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

HKHong KongMDACS

3valid listings

Class II 3

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

6active registrations

Class 2a 3Class 2b 3

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union17 raw hits, 0 excluded, 17 confirmed

United States13 registration records, 11 510(k), 0 PMA

United Kingdom9 confirmed, 0 excluded

Brazil5 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: Bistos co., ltd. · BISTOS CO., LTD. · Bistos Co., Ltd.

Regulatory identity

EU manufacturer SRN: KR-MF-000035951
EU authorised representative: Obelis s.a.
UK responsible person: Advena Ltd
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

12005

12010

12011

12012

12014

12015

12016

22021

12024

12025

FDA listed device types

Light, Examination, Medical, Battery Powered 1Transducer, Ultrasonic, Obstetric 1Pump, Breast, Powered 1Incubator, Neonatal 1Transcutaneous Nerve Stimulator For Adhd 1Colposcope (And Colpomicroscope) 1System, Monitoring, Perinatal 1Unit, Neonatal Phototherapy 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08800012341014	—	Class I
EU	08800012341007	—	Class I
EU	08800012378003	—	Class IIb
EU	08800012377006	—	Class IIb
UK	38478	Electric Breast Pump	Class IIa
UK	34040	Hi-bebe	Class IIa
UK	37796	Fetal monitor	Class IIa
US	K251512	Hi bebe super (BT-150B)	2025-09-25
US	K232991	BT-1000	2024-08-28
US	K210289	Infant Phototherapy Equipment	2021-05-28
BR	80153039022	Doppler Portátil BT-200V	Class II
BR	80070219032	MONITOR FETAL CARDIOTOCÓGRAFO HI-BEBE MD®	Class II
BR	80070219033	Doppler Fetal HI-BEBE S MD	Class II
SA	ME0000002537SFDAA00006	Head-Worn Light	—
SA	ME0000006280SFDAA00001	BT-410	—