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Facet Technologies, LLC.

USA · Atlanta

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

4 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

1valid listings

Class II 1

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 States5 registration records, 8 510(k), 0 PMA, 1 excluded

Brazil2 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Facet Technologies, LLC. · FACET TECHNOLOGIES, LLC · FACET TECHNOLOGIES LLC

FDA 510(k) clearances by year

32014 · K141749

32022 · K223099

12023 · K223370

12024 · K232912

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Needle, Hypodermic, Single Lumen 1Tape And Bandage, Adhesive 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232912	Facet Aurora Reusable Lancet Base	2024-01-25
US	K223370	NeatNick Heel Safety Lancet	2023-02-13
US	K223099	Facet Manatee Reusable Lancing Base	2022-11-28
BR	80146509049	FREESTYLE LANCETS / LANCETAS FREESTYLE	Class II
BR	81704410001	Curativo Sureseal Pressure Bandage	Class I
CA	93442	SAFETY LANCET	Class II
CA	80340	RENEW ADVANCED LANCING SYSTEM	Class II

Facet Technologies, LLC.

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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