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Acme Monaco Corporation

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, United Kingdom, South Korea, Australia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

8listed device types

Class I 5Class II 3Class III 0

plus 16 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class IIa 5

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

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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 States16 registration records, 5 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Manufacturer names merged into this page: ACME-MONACO CORP. · Acme Monaco Asia Pte. Ltd.

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

11988 · K883763

21990 · K895854

11992 · K920884

12012 · K113162

FDA listed device types

Spring, Orthodontic 1Clamp, Wire, Orthodontic 1Bracket, Metal, Orthodontic 1Guide, Surgical, Instrument 1Wire, Orthodontic 1Wire, Guide, Catheter 1Stylet, Catheter 1Tubes, Gastrointestinal (And Accessories) 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	41677	Ligatures	Class IIa
UK	35439	Lingual Palatal Bars	Class IIa
UK	38741	Hooks	Class IIa
US	K113162	SLIDEWIRETM(TRADEMARK PENDING)	2012-07-20
US	K920884	GUIDEWIRES, VARIOUS TYPES	1992-08-19
US	K895854	ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)	1990-04-09

Acme Monaco Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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