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Bertec Inc

USA · Columbus OH · www.bertec.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000008643

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Hong Kong, Israel — 8 overseas markets. EU UDI-DI records ≥10, the first 300 verified individually. 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

≥10UDI-DI device records

Class IIa 10

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

6registered device records

Class I 2Class IIa 4

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

1registrations

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.

European Union461 raw hits, 290 excluded, 10 confirmed. Large result set — only the first 300 verified

United States5 registration records, 1 510(k), 0 PMA, 1 excluded

United Kingdom6 confirmed, 1 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: BERTEC CORP. · BERTEC CORPORATION · Bertec Corporation

Regulatory identity

EU manufacturer SRN: US-MF-000008643
EU authorised representative: Emergo Europe B.V.
UK responsible person: Emergo Consulting (UK) Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00850017250116	—	Class IIa
EU	00850017250093	—	Class IIa
EU	00850017250000	—	Class IIa
EU	00850017250017	—	Class IIa
UK	64862	Bertec Vision Trainer (BVT) System	Class IIa
UK	47518	Bertec Head Mounted Display (HMD) System	Class IIa
UK	45584	Bertec Vision Advantage (BVA) System	Class I
US	K991642	EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX	1999-08-03
BR	81735869001	Plataforma Computadorizada de Avaliação Postural Dinâmica	Class II
SA	ME0000017905SFDAA00006	Type 1001	—
SA	ME0000017905SFDAA00004	Type 1003	—

Bertec Inc

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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