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Fabrication Enterprises Inc.

USA · Elmsford NY · fabent.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN US-MF-000014521

This company has registrations in European Union, United Kingdom, Saudi Arabia, Canada, Taiwan, Australia — 6 overseas markets. EU UDI-DI records ≥157, 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

≥157UDI-DI device records

Class I 157

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

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

31registered device records

Class I 31

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

9valid device licences

Class I 9

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

33active ARTG entries

Class I 33

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union1,367 raw hits, 143 excluded, 157 confirmed. Large result set — only the first 300 verified

United States0 registration records, 0 510(k), 0 PMA, 8 excluded

United Kingdom31 confirmed, 1 excluded

Saudi Arabia7 confirmed, 0 excluded

Manufacturer names merged into this page: FABRICATION ENTERPRISES · Fabrication Enterprises Incorporated

Regulatory identity

EU manufacturer SRN: US-MF-000014521
EU authorised representative: AJW Technology Consulting GmbH
UK responsible person: AJW Technology Consulting Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00714905013378	—	Class I
EU	00714905013606	—	Class I
EU	00714905013583	—	Class I
EU	00714905103079	—	Class I
UK	37986	CanDo ankle cuffs, pair, blue	Class I
UK	63453	Baseline back, leg, chest dynamometer, adolescent, 330lb	Class I
UK	41158	Cando 45cm (17.7in) ABS inflatable ball, yellow	Class I
SA	ME0000013121SFDAA00006	RELIEF PAK HEATING UNIT	—
SA	ME0000013121SFDAA00009	Gel Hand Exercise Balls	—

Fabrication Enterprises Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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