HomeTaiwanACRO BIOMEDICAL CO., LTD.

ACRO BIOMEDICAL CO., LTD.

Taiwan · Kaohsiung
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
4listed device types
Class I 2Class II 1Class III 0unclassified 1
plus 6 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
pendingnot queried
SGSingaporeHSA SMDR
3device registrations
CLASS D 3
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 States6 registration records, 4 510(k), 0 PMA, 5 excluded
Brazil0 confirmed, 5 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: ACRO BIOMEDICAL CO., LTD.

Company information

Country
Taiwan
City
Kaohsiung

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

12017 · K162348
12018 · K171629
12021 · K212156
12024 · K233378

FDA listed device types

Wound Dressing With Animal-Derived Material(S) 1Material, External Aesthetic Restoration, No Adhesive 1Elastomer, Silicone, For Scar Management 1Filler, Bone Void, Calcium Compound 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233378ABCcolla® Collagen ADM Scaffold2024-10-18
USK212156ABCcolla Bone Matrix2021-10-08
USK171629ABCcolla Bone Graft2018-02-01

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