HomeUSADEEP BLUE MEDICAL ADVANCES, INC.

DEEP BLUE MEDICAL ADVANCES, INC.

USA · Durham
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 61 510(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
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.

United States1 registration records, 61 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: DEEP BLUE MEDICAL ADVANCES, INC.
Same-named companies — This database also contains companies with near-identical names: Medical Advances, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Durham

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

51989
141990
71991
21992
31993
41994
61995
11997
41998
41999
32000
22001
22002
12020
12022
22023

FDA listed device types

Mesh, Surgical, Polymeric 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232924T-Line® Hernia Mesh2023-10-18
USK230227T-Line Hernia Mesh2023-02-23
USK221556T-Line Hernia Mesh2022-11-28

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