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SP Medikal San Ltd Sti

Türkiye · Bayrampasa -Istanbul Istanbul · www.spmedikal.com

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel — 6 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

199listed device types

Class I 78Class II 110Class III 10unclassified 1

plus 266 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

191registered devices

Class I 57Class II 134

199 including historic records

SASaudi ArabiaSFDA

239registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union41,027 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States266 registration records, 8 510(k), 0 PMA, 12 excluded

United Kingdom0 confirmed, 348 excluded

Brazil191 confirmed, 8 excluded

Saudi Arabia239 confirmed, 15 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: CARDIMED ASIA MEDIKAL SANAYI VE TICARET LTD STI · JETWEELS MEDIKAL SANAYI VE DIS TICARET LTD STI · VIZOR ORTOPEDI MEDIKAL URUNLERI PAZARLAMA ITHALAT IHRACAT SANAYI VE TICARET LTD STI · DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI · LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN. TIC. LTD. STI · OCCLUTECH TIBBI URUNLER SAN. VE TIC. LTD. STI.

FDA 510(k) clearances by year

22016 · K160595

22017 · K160850

12022 · K210148

22023 · K213100

12026 · K260277

FDA listed device types

showing 8 of 199

Electrosurgical, Cutting & Coagulation & Accessories 1Enzyme Immunoassay, Benzodiazepine 1Endoscopic Guidewire, Gastroenterology-Urology 1Cardiac C-Reactive Protein, Antigen, Antiserum, And Control 1Starch-Dye Bound Polymer, Amylase 1Conductivity Rate, Urea Nitrogen 1Washer, Bolt Nut 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260277	MIKRON TRAUMA BONE PLATE& SCREW SYSTEM	2026-08-13
US	K213100	FMT Reusable Temperature Probes	2023-07-18
US	K223300	Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument	2023-04-21
BR	81207910024	MAMEF	Class I
BR	81207910025	OWO-FIX	Class I
BR	81207910026	UMEF	Class I
SA	ME0000001216SFDAA00001	3ind 60gm Flat reel	—
SA	ME0000001216SFDAA00002	BOWIE DICK TEST PACK	—
CA	105510	LANSINOH COMPACT SINGLE ELECTRIC BREAST PUMP	Class II
CA	91656	AFFINITY DOUBLE ELECTRIC BREAST PUMP	Class II

SP Medikal San Ltd Sti

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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