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SIE AG SURGICAL INSTRUMENT ENGINEERING AG

Switzerland · Port

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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

4510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

4valid device licences

Class I 1Class II 2Class III 1

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 1IIb 1

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 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 States0 registration records, 4 510(k), 0 PMA, 2 excluded

Brazil7 confirmed, 0 excluded

Manufacturer names merged into this page: SIE AG SURGICAL INSTRUMENT ENGINEERING AG · SIE SURGICAL INSTRUMENT ENGINEERING AG

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213559	FEMTO LDV Z8 Femtosecond Surgical Laser	2022-04-21
US	K150323	FEMTO LDV Z8 Surgical Laser	2015-10-23
US	K112154	FEMTO LDV	2012-03-16
BR	80192019012	PROCEDURE PACK CATARACT CORNEAL SURGERY LIQUID	Class II
BR	80192019013	PROCEDURE PACK LASIK	Class II
BR	80192019014	PROCEDURE PACK LASIK / CORNEAL SURGERY	Class II

SIE AG SURGICAL INSTRUMENT ENGINEERING AG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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