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BIO PROTECH INC.

✓ Record-verifiedregistrations found in 6 marketsEU SRN KR-MF-000012687

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

151UDI-DI device records

Class I 55Class IIa 18Class IIb 78

USUnited StatesFDA openFDA

12listed device types

Class I 1Class II 11Class III 0

plus 44 registration records and 17 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 6Class IIa 1Class IIb 2

BRBrazilANVISA

19registered devices

Class I 15Class II 4

23 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 Union151 raw hits, 0 excluded, 151 confirmed

United States44 registration records, 17 510(k), 0 PMA, 10 excluded

United Kingdom9 confirmed, 1 excluded

Brazil19 confirmed, 3 excluded

Saudi Arabia4 confirmed, 1 excluded

Manufacturer names merged into this page: BIO PROTECH YANTAI INC · BIO PROTECH, INC. · BIO PROTECH INC. · BIO PROTECH INC · BIO PROTECH YAN TAI, INC · Bio Protech Inc.

Regulatory identity

EU manufacturer SRN: KR-MF-000012687
EU authorised representative: Meridius Medical Europe Limited
UK responsible person: DongBang AcuPrime Ltd
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

12002

22004

12005

12007

22008

32009

12010

12011

12014

12015

22016

12019

FDA listed device types

showing 8 of 12

Electrosurgical, Cutting & Coagulation & Accessories 1Electrode, Needle 1Stimulator, Muscle, Powered 1Cable, Electrode 1Electrode, Cutaneous 1Electrode, Electrocardiograph 1Interferential Current Therapy 1Apparatus, Exhaust, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809083945640	PROPLATE	Class IIb
EU	08809083945633	PROPLATE	Class IIb
EU	08809083945626	PROPLATE	Class IIb
EU	08809083945572	PROPLATE	Class IIb
UK	61020	EMG Surface Electrodes	Class I
UK	35035	ECG Electrodes	Class I
UK	17554	EEG Electrodes	Class I
US	K192035	EvaQMax Smoke Evacuation System	2019-08-29
US	K152984	Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes	2016-06-03
US	K153019	Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes	2016-03-21
BR	80722800003	ELETRODOS PARA ECG CARBONADO - MEDPEX	Class I
BR	80722800004	ELETRODOS PARA ECG - MEDPEX	Class I
BR	80451960135	NHP MEDICAL ELETRODO DESCARTÁVEL	Class I
SA	ME0000005146SFDAA00001	PRO NEO	—
SA	ME0000005146SFDAA00002	TELECTRODE	—

BIO PROTECH INC.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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