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SENZIME INC.

Sweden · Uppsala

✓ Record-verifiedregistrations found in 5 markets

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

4listed device types

Class I 0Class II 4Class III 0

plus 5 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

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.

United States5 registration records, 3 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Manufacturer names merged into this page: SENZIME AB · SENZIME INC.

FDA 510(k) clearances by year

12019 · K190795

12022 · K220530

12026 · K261098

FDA listed device types

Suture, Surgical, Absorbable, Polydioxanone 1Spirometer, Monitoring (W/Wo Alarm) 1Stimulator, Nerve, Peripheral, Electric 1Monitor, Breathing Frequency 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261098	TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)	2026-05-22
US	K220530	Tetragraph Neuromuscular Transmission Monitor	2022-08-17
US	K190795	Tetragraph Neuromuscular Transmission Monitor	2019-10-18
BR	83279929015	Eletrodos para Monitoração Neuromuscular 24 horas TetraGraph - pediátr	Class II
BR	83279929016	Eletrodos para Monitoração Neuromuscular até 30 dias TetraGraph - adul	Class II
BR	83279929020	Sistema de Monitoração Neuromuscular TetraGraph	Class II

SENZIME INC.

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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