HomeUSAAdvamedica Inc.

Advamedica Inc.

USA · Cambridge MA · www.advamedica.com
✓ 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
0UDI-DI device records
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 1Class III 0unclassified 2
plus 4 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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 States4 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: ADVAMEDICA INC.

Company information

Country
USA
City
Cambridge MA
Website
www.advamedica.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

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 · K172324
12021 · K202830
32023 · K212766

FDA listed device types

Wound Dressing With Animal-Derived Material(S) 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Temporary, Internal Use Hemostatic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK212766Maxiocel Chitosan Wound Dressing2023-08-24
USK222909Axiostat Gauze2023-04-07
USK213198Ax-Surgi Surgical Hemostat2023-01-05

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