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R&R Medical Corporation Ltd.

Taiwan · New Taipei City -Diistrict Xizhi Diistri · www.rr-medical.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, United Kingdom, Saudi Arabia — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

24listed device types

Class I 22Class II 2Class III 0

plus 24 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

1registered device records

Class I 1

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

11registered 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 Union714,378 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States24 registration records, 7 510(k), 0 PMA, 8,876 excluded

United Kingdom1 confirmed, 1,822 excluded

Brazil0 confirmed, 2,572 excluded

Saudi Arabia11 confirmed, 967 excluded

Canada0 confirmed, 1,238 excluded

Manufacturer names merged into this page: R&R Medical Corporation Ltd. · R&R MEDICAL CORPORATION LTD.

Regulatory identity

UK responsible person: TraumaMed Solutions Ltd.

FDA 510(k) clearances by year

11981 · K811303

11993 · K923464

32005 · K052005

12022 · K214035

12023 · K220226

FDA listed device types

showing 8 of 24

Sling, Arm, Overhead Supported 1Cushion, Flotation 1Mattress, Flotation Therapy, Non-Powered 1Splint, Hand, And Components 1Adhesive Backed Thermal Skin Patches 1Insoles, Medical 1Orthosis, Limb Brace 1Bag, Ice 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	67046	X8T Tourniquet	Class I
US	K220226	X-Y Lubricating Jelly	2023-03-28
US	K214035	LAITEST Medical Face Mask	2022-09-13
US	K052005	R&R EXTERNAL FIXATION SYSTEM	2005-09-06
SA	ME0000008105SFDAA00001	Super cool Instant Ice pack	—
SA	ME0000008105SFDAA00004	Rexicare soft Cold/HOT GEL BAGS	—

R&R Medical Corporation Ltd.

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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