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INTEGRATED ORBITAL IMPLANTS, INC.

USA · San Diego

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 3 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 2Class II 3Class 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

0active device licences

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS D 2

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, 2 excluded

Manufacturer names merged into this page: INTEGRATED ORBITAL IMPLANTS, INC. · INTEGRATED ORBITAL IMPLANTS INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K003338	BIO-EYE II ORBITAL IMPLANT	2001-02-07
US	K000151	PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE	2000-04-10
US	K982562	BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER	1998-12-28

INTEGRATED ORBITAL IMPLANTS, 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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