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Plasti-med Plastik Medikal Urunler Sanayi ve Ticaret Limited Sirketi

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 8 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

28listed device types

Class I 21Class II 7Class III 0

plus 28 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

95registered device records

Class I 6Class IIa 77Class IIb 11IVD general 1

BRBrazilANVISA

12registered devices

Class I 5Class II 7

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 Union7,221 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States28 registration records, 0 510(k), 0 PMA, 3 excluded

United Kingdom95 confirmed, 28 excluded

Brazil12 confirmed, 2 excluded

Saudi Arabia2 confirmed, 1 excluded

Manufacturer names merged into this page: PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI. · Plasti-Med Plastik Medikal ÜR. San Ve Tic. Ltd.sti · PLASTI-MED PLASTIK MEDICAL URUNLER LTD · Plasti-med · PLASTI-MED

Regulatory identity

UK responsible person: Vera Global Ltd

FDA listed device types

showing 8 of 28

Dislodger, Stone, Basket, Ureteral, Metal 1Catheter And Tip, Suction 1Bag, Urine Collection, Newborn 1Endoscopic Guidewire, Gastroenterology-Urology 1Bottle, Collection, Vacuum 1Speculum, Vaginal, Nonmetal 1Tube, Aspirating, Flexible, Connecting 1Mouthpiece, Breathing 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62162	Plastimed SYRINGE	Class IIa
UK	37704	Plastimed BREATHING CIRCUIT	Class IIa
UK	37704	Plastimed ANESTHESIA CIRCUIT	Class IIa
BR	10289680211	Canula de Karman Plasti-med	Class II
BR	10289680208	Seringa aspirativa de valvula unica para canulas de Karman Plasti-med	Class I
BR	80984190073	Cateter para Circuito de anestesia.	Class II
SA	ME0000014094SFDAA00005	ENMA SET	—
SA	ME0000009827SFDAA00001	FLURABSORB ACCESSORY KiT	—

Plasti-med Plastik Medikal Urunler Sanayi ve Ticaret Limited Sirketi

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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