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ACRA CUT, INC.

USA · Acton

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 9 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 2Class II 5

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

4active device licences

Class II 4

6 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

Class I 3IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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 States9 registration records, 8 510(k), 0 PMA

Brazil7 confirmed, 0 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: ACRA CUT, INC. · ACRA-CUT INC. · ACRA CUT INC

FDA 510(k) clearances by year

11983 · K833266

11989 · K892866

41991 · K911812

11994 · K944311

12003 · K032970

FDA listed device types

Drills, Burrs, Trephines & Accessories (Simple, Powered) 1Clip, Scalp 1Drills, Burrs, Trephines & Accessories (Compound, Powered) 1Instrument, Surgical, Disposable 1Applier, Surgical, Clip 1Instrument, Surgical, Non-Powered 1Instrument, Clip Removal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K032970	ACRA-CUT XPRESS 120	2003-12-08
US	K944311	ACRA-CUT	1994-11-18
US	K911812	ACRA-CUT WIRE PASS DRILL	1991-09-10
BR	80353100011	PERFURADOR CRANIANO DESCARTÁVEL ACRA-CUT	Class II
BR	80353100023	Conjunto de Instrumental para Craniotomia Acra-Cut	Class I
BR	80356130040	BROCAS PARA CRÂNIO ACRA-CUT	Class II
CA	71922	CRANIOBLADES	Class II
CA	71923	CRANIOTOMY KITS	Class II
CA	72120	WIRE PASS DRILLS	Class II

ACRA CUT, INC.

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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