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STOCKERT GMBH

Germany · Freiburg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

5listed device types

Class I 0Class II 2Class III 3

plus 6 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 1Class II 2

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

3active device licences

Class II 2Class III 1

7 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

9active ARTG entries

Class I 3IIa 4IIb 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 2Class 2b 3

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 States6 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: STOCKERT GMBH

FDA 510(k) clearances by year

12001 · K003983

12005 · K052313

12006 · K061983

22007 · K070336

FDA listed device types

Catheter, Electrode Recording, Or Probe, Electrode Recording 1Stimulator, Nerve, Battery-Powered 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter 1Cardiac Ablation Percutaneous Catheter 1Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K070336	STOCKERT NEURO N50, MODEL12267	2007-06-14
US	K070134	MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098	2007-03-22
US	K061983	STIMUPLEX PEN	2006-11-21
BR	80224390229	CABO DE CONEXÃO PARA GERADOR RF STOCKERT	Class II
BR	80136990463	ESTIMULADORES DOS NERVOS PARA ANESTESIA REGIONAL, ANALGESIA REGIONAL,	Class II
BR	10341350736	CABO DE CATETER	Class I
CA	32873	NEURO N-50 ELECTROSURGICAL DEVICE	Class III
CA	36380	STIMUPLEX HNS-11	Class II
CA	90297	CATHETER CONNECTION CABLE	Class II