HomeUSAR.K. Manufacturing

R.K. Manufacturing

USA · Danbury
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 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
pendingnot queried
USUnited StatesFDA openFDA
38listed device types
Class I 17Class II 21Class III 0
plus 47 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
Class I 2
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.

United States47 registration records, 5 510(k), 0 PMA, 599 excluded
Brazil0 confirmed, 102 excluded
Saudi Arabia0 confirmed, 58 excluded
Canada0 confirmed, 68 excluded
Manufacturer names merged into this page: R.K. Manufacturing · V&Q Manufacturing Corporation · R.E.C. MANUFACTURING CORPORATION

Company information

Country
USA
City
Danbury

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12018 · K173062
42020 · K201532

FDA listed device types

showing 8 of 38
Cap, Surgical 1Cover, Cast 1Finger Cot 1Accessory, Surgical Apparel 1Bag, Ice 1Apron, Protective 1Gown, Examination 1Non-Surgical Gown 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201532B&J DVT Calf/Thigh Garments, Models 801/830 Series2020-09-19
USK201547B&J DVT Foot Garments, Models 820 Series2020-09-18
USK200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System2020-07-10

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