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GREATBATCH MEDICAL SA

USA · Minneapolis

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

26listed device types

Class I 3Class II 10Class III 12unclassified 1

plus 57 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

8 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

18active device licences

Class II 16Class IV 2

25 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

3device registrations

CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 8Class III 2IIa 3IIb 1

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 1Class 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.

Australia, Hong Kong, Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.

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 States57 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil2 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada18 confirmed, 0 excluded

Manufacturer names merged into this page: Greatbatch Medical · Greatbatch Medical, S. de R.L. de C.V. · Greatbatch Medical S. de R.L. de C.V. · CPE1, LLC DBA Greatbatch Medical · GREATBATCH MEDICAL · GREATBATCH MEDICAL SA

FDA listed device types

showing 8 of 26

Implantable Pulse Generator 1Stimulator, Hypoglossal Nerve, Implanted, Apnea 1Stimulator, Spinal-Cord, Totally Implanted For Pain Relief 1Implant, Auditory Brainstem 1Permanent Pacemaker Electrode 1Pacemaker/Icd/Crt Non-Implanted Components 1Implant, Cochlear 1Automated External Defibrillators (Non-Wearable) 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80102510883	FERRAMENTA PARA IMPLANTAÇÃO DE ELETRODOS FASTAC® FLEX	Class II
BR	80012450018	KIT DE FRESAS INTRA-MODULARES FLEXÍVEIS DE NITINOL	Class I
CA	88896	MOBICATH TRANSSEPTAL NEEDLE	Class II
CA	16746	MEDAMICUS PERCUTANEOUS INTRODUCER SYSTEM	Class II
CA	23670	LUMAX CYSTOMETRY SYSTEM	Class II