HomeUSAAllosource, Inc.

Allosource, Inc.

USA · Centennial
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Taiwan, Israel — 3 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
6listed device types
Class I 0Class II 6Class III 0
plus 10 registration records and 4 510(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
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States10 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: ALLOSOURCE

Company information

Country
USA
City
Centennial

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

12008 · K071849
12011 · K103036
12018 · K170957
12023 · K213046

FDA listed device types

Filler, Bone Void, Calcium Compound 1Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon 1Mesh, Surgical 1Cuff, Nerve 1

Registration details (sample)

MarketIdentifierNameClass / date
USK213046AceConnex Pre-Sutured Fascia2023-06-27
USK170957ReConnex Pre-Sutured Tendon2018-03-20
USK103036ALLOFUSE PLUS2011-01-10

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