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Optomic España, S.A.

Spain · Colmenar Viejo (Madrid) · www.optomic.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN ES-MF-000003235

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Taiwan, Australia, Israel, Russia — 8 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

92UDI-DI device records

Class I 85Class IIa 7

USUnited StatesFDA openFDA

11listed device types

Class I 10Class II 1Class III 0

plus 11 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

10registered device records

Class I 9Class IIa 1

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

25registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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.

European Union92 raw hits, 0 excluded, 92 confirmed

United States11 registration records, 0 510(k), 0 PMA

United Kingdom10 confirmed, 0 excluded

Saudi Arabia25 confirmed, 0 excluded

Manufacturer names merged into this page: OPTOMIC ESPANA, S.A. · OPTOMIC ESPANA S.A. · OPTOMIC ESPAÑA, S.A.

Regulatory identity

EU manufacturer SRN: ES-MF-000003235
UK responsible person: CMC Medical Devices LTD

FDA listed device types

showing 8 of 11

Chair, Surgical, Ac-Powered 1Laryngoscope, Rigid 1Microscope, Surgical 1Laryngoscope, Non-Rigid 1Source, Carrier, Fiberoptic Light 1Unit, Examining/Treatment, Ent 1Microscope, Operating & Accessories, Ac-Powered, Ophthalmic 1Laryngostroboscope 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08436041581642	OCULA	Class I
EU	08436041581581	OP-C5 DC	Class I
EU	08436041581604	OPT ø6x70º AUT. Great Magnification	Class I
EU	08436041581611	OP-HL CAM	Class I
UK	10960	COLPOSCOPE	Class I
UK	47146	ENT CHAIRS	Class I
UK	11585	WORKSTATIONS	Class IIa
SA	ME0000000238SFDAA00002	FIBROLUX LED HP	—
SA	ME0000004632SFDAA00002	OP-HL15 LED HEAD LAMP	—

Optomic España, S.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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