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ACME United Europe GmbH

Germany · Solingen · www.acmeunited.de

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

32listed device types

Class I 29Class II 2Class III 0unclassified 1

plus 61 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

pendingnot queried

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.

European Union336 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States61 registration records, 27 510(k), 0 PMA, 13 excluded

United Kingdom0 confirmed, 5 excluded

Brazil0 confirmed, 3 excluded

Manufacturer names merged into this page: ACME UNITED CORP. · Acme United Corporation - My Medic

Business registration

LEI: 529900C5NO86OHROJN19
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1983-01-13
Registered address: Junkerstr. 13, Solingen, 42699
Registration authority: Commercial Register, no. HRB 15127
Registry record updated: 2026-08-10

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

21976

31977

11978

21979

11980

21981

11982

31983

31984

41986

11987

11990

11995

21996

FDA listed device types

showing 8 of 32

Stretcher, Hand-Carried 1Pad, Eye 1Forceps 1Mouthpiece, Breathing 1First Aid Kit Without Drug 1Snake Bite Suction Kit 1Personal Protection Kit 1Bedding, Disposable, Medical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K961323	LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING	1996-06-19
US	K961452	LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING	1996-05-31
US	K952565	LYOFOAM EXTRA	1995-11-14

ACME United Europe GmbH

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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