SG Medical S.A.

Switzerland · Geneva · www.sgmedical.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 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

0UDI-DI device records

USUnited StatesFDA openFDA

47listed device types

Class I 44Class II 3Class III 0

plus 50 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

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.

European Union2,650 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States50 registration records, 4 510(k), 0 PMA, 9 excluded

United Kingdom0 confirmed, 26 excluded

Brazil0 confirmed, 3 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: KENAD SG MEDICAL, INC. · BOTHWIN MEDICAL TECHNOLOGY (SG) PTE. LTD.

FDA 510(k) clearances by year

41996 · K963421

FDA listed device types

showing 8 of 47

Forceps 1Orthosis, Lumbar 1Scissors, Orthopedic, Surgical 1Splint, Hand, And Components 1Handle, Scalpel 1Snare, Surgical 1Punch, Surgical 1Guide, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K963421	PROTECTIVE RESTRAINT (WAIST HOLDER)	1996-11-22
US	K963430	PROTECTIVE RESTRAINT (VEST RESTRAINT)	1996-11-22
US	K963422	PROTECTIVE RESTRAINT (PROTECTIVE MITT)	1996-11-22

SG Medical S.A.

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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