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LUVO MEDICAL TECHNOLOGIES, INC.

Canada · Cambridge

✓ 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

5listed device types

Class I 1Class II 4Class III 0

plus 5 registration records and 5 510(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

7active device licences

Class II 7

66 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 States5 registration records, 5 510(k), 0 PMA

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: LUVO MEDICAL TECHNOLOGIES, INC.

FDA 510(k) clearances by year

22020 · K193446

32021 · K212607

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Powered Laser Surgical Instrument 1Platelet And Plasma Separator For Bone Graft Handling 1Powered Light Based Non-Laser Surgical Instrument With Thermal Effect 1Brush, Dermabrasion, Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212607	Darwin	2021-11-15
US	K210129	RF Thermal System	2021-07-20
US	K203728	Darwin	2021-07-14
CA	90620	NAVIJECT LENS INJECTION SYSTEM	Class II
CA	96873	ENVY SILKPEEL DERMABRASION SYSTEM	Class II
CA	102354	MACULOGIX ADAPTDX (DARK ADAPTOMETER)	Class II

LUVO MEDICAL TECHNOLOGIES, INC.

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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