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Demetech Corporation

USA · Miami Lakes FL · www.demetech.us

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000026972

This company has registrations in European Union, United States, Brazil, Canada, Taiwan, Australia, Israel — 7 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 IIb 45Class III 255

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

USUnited StatesFDA openFDA

19listed device types

Class I 5Class II 14Class III 0

plus 24 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

7registered devices

Class II 7

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

1active device licences

Class III 1

2 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 2Class III 5IIb 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

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 Union2,956 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States24 registration records, 16 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DEMETECH CORP. · DEMETECH CORP · DEMETECH CORPORATION

Regulatory identity

EU manufacturer SRN: US-MF-000026972
EU authorised representative: Obelis s.a.

FDA 510(k) clearances by year

12002

22003

12004

22005

12008

12010

12013

22014

22018

22019

12020

FDA listed device types

showing 8 of 19

Suture, Surgical, Absorbable, Polydioxanone 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Suture, Nonabsorbable, Silk 1Suture, Absorbable, Natural 1Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Collector, Urine, (And Accessories) For Indwelling Catheter 1Respirator, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	10652927671268	DemeTECH PTFE	Class IIb
EU	10652927432241	DemeTECH PTFE	Class IIb
EU	10652927219484	DemeSORB	Class III
EU	10652927187387	DemeSORB	Class III
US	K201479	DemeMASK	2020-07-24
US	K191361	DemeDIOX Barbed Absorbable Surgical Suture	2019-11-07
US	K190777	DemeTECH DemeFORCE Nonabsorbable Surgical Suture	2019-07-31
BR	80808489023	DemeLON	Class II
BR	80808489024	DemeLENE	Class II
BR	80808489025	DemeLON MULTI	Class II
CA	98207	DEMELENE - POLYPROPYLENE NONABSORBABLE SUTURE	Class III

Demetech Corporation

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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