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Brownmed

USA · Auburndale MA · www.brownmed.com

✓ Record-verifiedregistrations found in 5 marketsEU SRN US-MF-000008271

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Australia — 5 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 I 300

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 19Class II 0Class III 0

plus 19 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

18registered device records

Class I 18

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered 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

3active ARTG entries

Class I 3

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 Union336 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States19 registration records, 0 510(k), 0 PMA

United Kingdom18 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: Brownmed · Brownmed, Inc

Regulatory identity

EU manufacturer SRN: US-MF-000008271
EU authorised representative: AR Experts B.V.
UK responsible person: UKCA Experts Ltd

FDA listed device types

showing 8 of 19

Splint, Hand, And Components 1Splint, Extremity, Noninflatable, External, Sterile 1Orthosis, Limb Brace 1Restraint, Protective 1Hand, External Limb Component, Mechanical 1Massager, Therapeutic, Electric 1Pack, Hot Or Cold, Reusable 1Tape And Bandage, Adhesive 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00821617134113	EHC-L Extended Heel Cushion	Class I
EU	00649833201576	Arthritis Elbow Sleeve	Class I
EU	00649833201569	Arthritis Elbow Sleeve	Class I
EU	00649833201552	Arthritis Elbow Sleeve	Class I
UK	36206	NICE STRETCH® X Lite	Class I
UK	65192	IMAK® COMPRESSION SHIN SLEEVE™	Class I
UK	64560	SEAL-TIGHT® - Freedom	Class I
SA	ME0000003531SFDAA00001	SoftStride	—

Brownmed

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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