HomeUSAThe Marena Group, LLC

The Marena Group, LLC

USA · Lawrenceville GA · www.marena.com
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Israel, Russia — 8 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
6listed device types
Class I 6Class II 0Class III 0
plus 6 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
1registered device records
Class I 1
BRBrazilANVISA
1registered devices
Class I 1
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
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 States6 registration records, 0 510(k), 0 PMA
United Kingdom1 confirmed, 0 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: THE MARENA GROUP, LLC. · THE MARENA GROUP, LLC · The Marena Group Inc.

Regulatory identity

UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
USA
City
Lawrenceville GA
Website
www.marena.com
Product categories
Digital Medicine, Data & Artificial IntelligenceWearables

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 listed device types

Prosthesis, Breast, External, No Adhesive 1Orthosis, Abdominal 1Binder, Medical, Therapeutic 1Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use 1Stocking, Elastic 1Bandage, Elastic 1

Registration details (sample)

MarketIdentifierNameClass / date
UK61223Marena NOA Compression ProductsClass I
BR80117580785MARENA RECOVERYClass I
SAME0000010968SFDAA00001Marena Recovery Compression Product

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