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PREDO SAGLIK URUNLERI SANAYI VE TICARET

Türkiye · Gazi̇antep · www.unipredo.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Saudi Arabia — 3 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

0UDI-DI device records

USUnited StatesFDA openFDA

4listed device types

Class I 4Class II 0Class III 0

plus 4 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class I 1

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

United States4 registration records, 0 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: PREDO SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI · Predo saglik urunleri sanayi ve ticaret a.ş.

Regulatory identity

UK responsible person: CULTCARE LTD

Market	Identifier	Name	Class / date
UK	11239	ELDEN ADULT DIAPER EXTRA LARGE	Class I
SA	ME0000000621SFDAA00007	Predo adult diaper	—

PREDO SAGLIK URUNLERI SANAYI VE TICARET

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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