OD-OS GMBH

Germany · Teltow

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Russia — 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

5listed device types

Class I 2Class II 3Class III 0

plus 2 registration records and 4 510(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

1active device licences

Class III 1

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States2 registration records, 4 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: OD-OS GMBH

FDA 510(k) clearances by year

12009 · K091064

12015 · K141851

12016 · K162191

12025 · K251772

FDA listed device types

Powered Laser Surgical Instrument 1Laser, Ophthalmic 1Camera, Ophthalmic, Ac-Powered 1Device, Storage, Images, Ophthalmic 1Device, Communications, Images, Ophthalmic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251772	Navilas Laser System 577sl (156691)	2025-10-29
US	K162191	NAVILAS Laser System	2016-11-22
US	K141851	NAVILAS LASER SYSTEM	2015-01-02
CA	92153	NAVILAS NAVIGATED LASER THERAPY	Class III

OD-OS GMBH

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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