HomeFranceMedica Holdings, LLC

Medica Holdings, LLC

France · Bedford
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia — 6 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
59listed device types
Class I 18Class II 40Class III 0unclassified 1
plus 47 registration records and 61 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
27registered devices
Class I 6Class II 21
30 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
13 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
IVD import 3
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2IIa 3IIb 3Class Im (measuring) 1
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, 61 510(k), 0 PMA, 46 excluded
Brazil27 confirmed, 43 excluded
Saudi Arabia0 confirmed, 7 excluded
Canada2 confirmed, 10 excluded
Manufacturer names merged into this page: AB MEDICA SAS · MEDICA CORP. · MEDICA CORPORATION · MEDICA HOLDINGS, LLC

Company information

Country
France
City
Bedford

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

11998
21999
12000
12001
12002
22007
42008
62009
32010
92011
12012
22013
22014
12015
22016
12017
12018
22023
12024
12026

FDA listed device types

showing 8 of 59
Electrosurgical, Cutting & Coagulation & Accessories 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Electrode, Ion-Specific, Chloride 1Catalytic Methods, Amylase 1Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252957Pneumo Dissector Hook2026-01-23
USK220328EasyStat 3002024-07-26
USK220396EasyStat 3002023-09-26
BR80115310228Solução Corante Vermelha para TesteClass I
BR80115310229EASYLYTE NA/K - ANALISADOR BIOQUIMICOClass II
BR80115310232EASYLYTE NA/K/LI - ANALISADOR BIOQUIMICOClass II
CA100271VIBRAPEP OSCILLATORY PEP THERAPY DEVICEClass II
CA106223MEDICA SINGLE-USE RIGID STYLETClass II

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