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Pearl, Inc.

USA · West Hollywood

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Australia, 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 8 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

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 States8 registration records, 8 510(k), 0 PMA, 6 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: PEARL INC. · Pearl Inc

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250525	Second Opinion® Panoramic	2025-11-14
US	K243234	Second Opinion® CS	2025-06-12
US	K243989	Second Opinion® 3D	2025-05-23
BR	83084440006	Second Opinion	Class II
SA	ME0000000535SFDAA00447	Second Opinion	—

Pearl, 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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