STERLAB

France · Signes Var

✓ 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

37listed device types

Class I 14Class II 20Class III 1unclassified 2

plus 67 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

4registered 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

4active ARTG entries

Class I 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States67 registration records, 0 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Manufacturer names merged into this page: STERLAB · Sterlab

FDA listed device types

showing 8 of 37

Apparatus, Hemoperfusion, Sorbent 1Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Prosthesis, Finger, Constrained, Polymer 1Lens, Contact, Polymethylmethacrylate, Diagnostic 1Injector, Contrast Medium, Automatic 1Device, Cystometric, Hydraulic 1Active Implantable Bone Conduction Hearing System 1Surgical Film 1

Market	Identifier	Name	Class / date
BR	81655779035	ROBÔ TELEMANIPULADOR ILY®	Class II
SA	ME0000010867SFDAA00001	Bodipack plus	—
SA	ME0000010867SFDAA00002	Emulating Indicator	—

STERLAB

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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