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ACUDERM, INCORPORATED

USA · Fort Lauderdale

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Australia, Israel — 4 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

7listed device types

Class I 4Class II 3Class III 0

plus 7 registration records and 13 510(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

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 1Class Is (sterile) 1

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 States7 registration records, 13 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ACUDERM, INC. · ACUDERM, INCORPORATED

FDA 510(k) clearances by year

41983

11986

11987

11989

11992

11993

41994

FDA listed device types

Apparatus, Exhaust, Surgical 1Powered Laser Surgical Instrument 1Needle, Hypodermic, Single Lumen 1Scissors, General, Surgical 1Kit, Surgical Instrument, Disposable 1Curette, Surgical, General Use 1Punch, Surgical 1

Market	Identifier	Name	Class / date
US	K933516	ACU-E PUNCH	1994-03-24
US	K933265	ACU-DISPO-CE(TM)	1994-03-07
US	K933137	ACU-SUTURE KIT	1994-02-22
CA	75456	ACU-EVAC	Class II

ACUDERM, INCORPORATED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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