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Su Biyomedikal Sistemler ve Sağlık Hizm.San.ve Tic. A.Ş.

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, United Kingdom — 2 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

17listed device types

Class I 10Class II 6Class III 0unclassified 1

plus 17 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 5Class IIa 2

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered 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.

European Union388,986 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States17 registration records, 1 510(k), 0 PMA

United Kingdom7 confirmed, 615 excluded

Manufacturer names merged into this page: GLOBAL BIYOMEDIKAL SAGLIK HIZMETLERI SANAYI VE TICARET LIMITED SIRKETI · Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S. · BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI

Regulatory identity

UK responsible person: Reflex Medical Limited

FDA 510(k) clearances by year

12024 · K233001

FDA listed device types

showing 8 of 17

Tray, Start/Stop (Including Contents), Dialysis 1Kit, Surgical Instrument, Disposable 1Non-Surgical Gown 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Expander, Surgical, Skin Graft 1Device, Intravascular Catheter Securement 1System, Suspension, Cell Culture 1Filters, Cell Collection, Tissue Processing 1

Market	Identifier	Name	Class / date
UK	33961	Maternity Pack	Class IIa
UK	16866	Catheter Protection Pouch	Class I
UK	33961	Abdominal Drape Set	Class I
US	K233001	Bioscope Neuromonitor Device	2024-12-13

Su Biyomedikal Sistemler ve Sağlık Hizm.San.ve Tic. A.Ş.

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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