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Retractable Technologies, Inc.

USA · Little Elm TX · www.retractable.com

✓ Record-verifiedregistrations found in 8 marketsEU SRN US-MF-000031781

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel — 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

5UDI-DI device records

Class IIa 3Class IIb 2

USUnited StatesFDA openFDA

6listed device types

Class I 0Class II 6Class III 0

plus 11 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class IIa 1

BRBrazilANVISA

8registered devices

Class 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

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 4

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 1IIa 11IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union5 raw hits, 0 excluded, 5 confirmed

United States11 registration records, 13 510(k), 0 PMA

United Kingdom1 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: RETRACTABLE TECHNOLOGIES, INC. · RETRACTABLE TECHNOLOGIES INC · RETRACTABLE TECHNOLOGIES INC.

Regulatory identity

EU manufacturer SRN: US-MF-000031781
EU authorised representative: MDSS GmbH
UK responsible person: MDSS-UK RP LIMITED

Business registration

Legal name: RETRACTABLE TECHNOLOGIES INC
CIK: 0000946563
Registration status: Active
Listing status: Listed (RVP)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11995

31997

11998

12005

12007

12008

22011

12013

12014

12021

FDA listed device types

Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Syringe, Antistick 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00613703101600	VanishPoint Syringe	Class IIa
EU	00613703240101	VanishPoint Blood Collection Set	Class IIb
EU	00613703312204	VanishPoint IV Catheter	Class IIb
EU	00613703852106	EasyPoint Needle	Class IIa
UK	32592	VanishPoint Tuberculin Syringe	Class IIa
US	K202325	EasyPoint Blood Collection Plus	2021-04-09
US	K133635	EASYPOINT NEEDLE	2014-06-17
US	K122355	VANISHPOINT BLOOD COLLECTION SET	2013-08-23
BR	80357660006	Conjunto de Coleta de Sangue VanishPoint	Class II
BR	80357660004	CATETER I. V. VANISHPOINT	Class II
BR	80357660002	SERINGA VANISHPOINT	Class II

Retractable Technologies, Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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