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BIOELECTRONICS CORPORATION

USA · Frederick

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Israel — 5 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

pendingnot queried

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 2 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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.

United States2 registration records, 3 510(k), 0 PMA, 2 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: BIOELECTRONICS CORPORATION

FDA 510(k) clearances by year

12017 · K152432

12019 · K190251

12020 · K192234

FDA listed device types

Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain 1Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat 1

Market	Identifier	Name	Class / date
US	K192234	ActiPatch	2020-01-31
US	K190251	RecoveryRx	2019-06-28
US	K152432	ActiPatch(R)	2017-02-03
CA	82850	ALLAY MENSTRUAL PAIN THERAPY	Class II

BIOELECTRONICS CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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