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Parker Laboratories Inc.

✓ Record-verifiedregistrations found in 11 marketsEU SRN US-MF-000013857

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 11 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

55UDI-DI device records

Class I 53Class IIa 2

USUnited StatesFDA openFDA

9listed device types

Class I 3Class II 6Class III 0

plus 15 registration records and 30 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 6Class IIa 1

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

26registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

4 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

14active ARTG entries

Class I 12IIa 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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 Union55 raw hits, 0 excluded, 55 confirmed

United States15 registration records, 30 510(k), 0 PMA, 12 excluded

United Kingdom7 confirmed, 2 excluded

Brazil2 confirmed, 1 excluded

Saudi Arabia26 confirmed, 0 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: PARKER LABORATORIES, INC. · PARKER LABORATORIES INC. · Parker Laboratories, Inc · Parker Laboratories Inc · Parker laboratories,Inc.

Regulatory identity

EU manufacturer SRN: US-MF-000013857
EU authorised representative: Parker Laboratories, BV
UK responsible person: MDSS-UK RP LIMITED

Business registration

LEI: 549300MC8J4BNV87G149
Registration status: Active
Legal form: Business Corporation
Registered address: 286 Eldridge Road, Fairfield, 07004
Registry record updated: 2023-08-04

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

FDA 510(k) clearances by year

61977

21978

41979

31980

11981

31982

11983

21984

21985

31986

11995

11996

12024

FDA listed device types

showing 8 of 9

Electrosurgical, Cutting & Coagulation & Accessories 1Media, Electroconductive 1Foam Or Gel Chemical Sterilant/High Level Disinfectant 1System, Imaging, Pulsed Echo, Ultrasonic 1Apparatus, Electrosurgical 1Media, Coupling, Ultrasound 1Tape And Bandage, Adhesive 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00855683006029	Sterile Aquasonic 100	Class IIa
EU	00855683006005	Sterile Aquasonic 100	Class IIa
EU	00855683006685	Gammacore Electrode Gel	Class I
EU	10855683006248	SignaCreme	Class I
UK	44713	Eclipse	Class I
UK	11425	BioWrap	Class I
UK	11425	Alpha-Stim Conductive Solution	Class I
US	K233965	UltraDrape UGPIV Barrier and Securement (34-15)	2024-08-15
US	K953673	ECLIPSE PROBE COVER	1996-03-14
US	K921695	ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS	1995-02-23
BR	81626449002	Gel para Ultrassonografia Estéril Aquasonic®	Class I
BR	81626440027	Película Protetora para Punção Periférica Guiada por Ultrassom	Class I
SA	ME0000007893SFDAA00004	Aquasonic 100 Ultrasound Transmission Gel	—
SA	ME0000007893SFDAA00005	Aquasonic Clear Ultrasound Gel	—
CA	1748	NATURAL LATEX ULTRASOUND PROBE COVERS NON-STERILE	Class II