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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.

Hong Kong, Saudi Arabia, 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.

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

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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