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SIVANTOS PTE LTD

Germany · Erlangen Bavaria

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, 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

7listed device types

Class I 0Class II 7Class III 0

plus 12 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

32valid device licences

Class I 31Class II 1

SGSingaporeHSA SMDR

27device registrations

CLASS B 27

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

8active ARTG entries

Class I 3IIa 5

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

14active registrations

Class 2a 14

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 States12 registration records, 1 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Manufacturer names merged into this page: Sivantos GmbH · SIVANTOS PTE LTD · SIVANTOS GMBH

FDA 510(k) clearances by year

12026 · K260614

FDA listed device types

Self-Fitting Air-Conduction Hearing Aid, Over The Counter 1Masker, Tinnitus 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Audiometer 1Self-Fitting Air-Conduction Hearing Aid, Prescription 1Hearing Aid, Air-Conduction With Wireless Technology, Prescription 1Calibrator, Hearing Aid / Earphone And Analysis Systems 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260614	Tinnitus Therapy	2026-06-10
BR	80872839006	Aparelhos de Audição Intracanal Digital A&M	Class II
BR	80872839007	Aparelhos de Audição Retro Digital A&M	Class II
BR	80872830004	APARELHO AUDITIVO RETRO DIGITAL REXTON	Class II