Home›Türkiye›MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

✓ Record-verifiedregistrations found in 6 marketsEU SRN TR-MF-000014943

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Australia — 6 overseas markets. EU UDI-DI records ≥300, 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

≥300UDI-DI device records

Class IIa 300

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

USUnited StatesFDA openFDA

22listed device types

Class I 14Class II 8Class III 0

plus 28 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

31registered device records

Class IIa 31

BRBrazilANVISA

9registered devices

Class I 1Class II 8

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

5 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

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 Union1,195 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

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

United Kingdom31 confirmed, 0 excluded

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. · MEDITERA TIBBI MALZEME SAN. VE TIC. A.S. · MEDITERA TIBBI MALZEME SAN. VE TIC.A.&#350. · MEDITERA TIBBI MALZEME SAN. VE TIC.A.S

Regulatory identity

EU manufacturer SRN: TR-MF-000014943
UK responsible person: Advena Ltd

FDA 510(k) clearances by year

22020 · K192713

12021 · K210992

FDA listed device types

showing 8 of 22

Filter, Bacterial, Breathing-Circuit 1Accessories, Pump, Infusion 1Pump, Infusion 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Valve, Non-Rebreathing 1Set, Administration, Intravascular 1Humidifier Nebulizer Kit 1Device, Positive Pressure Breathing, Intermittent 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	+M485AL1121060V0081X	ALTECH	Class IIa
EU	+M485AL1121060V0071W	ALTECH	Class IIa
EU	+M485AL1120V0081Q	ALTECH	Class IIa
EU	+M485AL080259V00712	ALTECH	Class IIa
UK	37704	BREATHING CIRCUIT, ADULT, CORRUGATED WITH BAG, STERILE	Class IIa
UK	37704	BREATHING CIRCUIT, ADULT, COAXIAL	Class IIa
UK	37704	BREATHING CIRCUIT, ADULT, CORRUGATED, BREATHING BAG, STERILE	Class IIa
US	K210992	Altech® Exhalation Valve (Single Limb and Dual Limb)	2021-12-23
US	K192713	Altera Filter and HME/Filter	2020-03-16
US	K192563	Altera gas Sampling Lines	2020-01-17
BR	81998999005	Altech Circuito de Anestesia com Tubo Expansível e Bolsa	Class II
BR	81333810005	Altech® Barrier Cream - Creme de barreira	Class I
BR	81998999006	Altech Máscara para Anestesia com Coxim Inflável	Class II

MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.

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)

Similar companies