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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.

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

Same-named companies — This database also contains companies with near-identical names: Greatbatch Ltd., d/b/a Greatbatch Medical, Greatbatch Medical, S. de R.L. de C.V.. Company name alone cannot separate their registrations, so the figures below may include either.

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
SA	ME0000000299SFDAA00005	Jumbo Case Lid for Acetabular Reamers	—
SA	ME0000000299SFDAA00006	Low Profile Acetabular Reamer Case	—
CA	88896	MOBICATH TRANSSEPTAL NEEDLE	Class II
CA	16746	MEDAMICUS PERCUTANEOUS INTRODUCER SYSTEM	Class II
CA	23670	LUMAX CYSTOMETRY SYSTEM	Class II

GREATBATCH MEDICAL SA

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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