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R&D Medical Products, Inc.

USA · Lake Forrest CA · www.rdmedicalproducts.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, United Kingdom — 2 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

9listed device types

Class I 6Class II 3Class III 0

plus 12 registration records and 59 510(k)

UKUnited KingdomMHRA PARD

27registered device records

Class I 27

BRBrazilANVISA

0registered devices

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 Union56,205 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States12 registration records, 59 510(k), 0 PMA, 665 excluded

United Kingdom27 confirmed, 247 excluded

Brazil0 confirmed, 399 excluded

Saudi Arabia0 confirmed, 278 excluded

Canada0 confirmed, 194 excluded

Manufacturer names merged into this page: R & D MEDICAL PRODUCTS, INC. · F & L MEDICAL PRODUCTS LLC

Regulatory identity

UK responsible person: SPIRIT MEDICAL LTD

FDA 510(k) clearances by year

41980

11981

11983

11984

21985

21986

11987

41988

31989

31992

21993

51994

81995

101996

21998

11999

12000

12009

12011

12013

FDA listed device types

showing 8 of 9

Electrode, Cutaneous 1Electrode, Electrocardiograph 1Stimulator, Nerve 1Pack, Hot Or Cold, Disposable 1Radiographic Protective Glove 1Shield, Protective, Personnel 1Tape And Bandage, Adhesive 1Cushion, Earphone (For Audiometric Testing) 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	35091	Sterile Surgical Gown - High Performance	Class I
UK	47783	Surgical Drape	Class I
UK	35091	Surgical Gown	Class I
US	K131023	THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN	2013-10-11
US	K111555	CIRCUMAURAL ADHESIVE REPLACEMENT	2011-07-25
US	K092744	NEONATAL ECG ELECTRODE, M203KEN	2009-12-10

R&D Medical Products, Inc.

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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