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THE PROMETHEUS GROUP

USA · Dover

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 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

7listed device types

Class I 0Class II 7Class III 0

plus 11 registration records and 11 510(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

2active device licences

Class II 2

8 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.

United States11 registration records, 11 510(k), 0 PMA, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: THE PROMETHEUS GROUP

FDA 510(k) clearances by year

11991

21996

31997 · K974036

22000 · K001515

22003 · K030039

12016 · K160792

FDA listed device types

Device, Cystometric, Hydraulic 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Uroflowmeter 1Perineometer 1Device, Biofeedback 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160792	Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound	2016-04-15
US	K030039	PATHWAY STM-10 PELVIC FLOOR STIMULATOR	2003-05-23
US	K023906	PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM	2003-02-19
CA	74358	DUO BIOFEEDBACK UROFLOW METER	Class II
CA	79694	CTS2000	Class II

THE PROMETHEUS GROUP

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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