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GIMMI

www.gimmi.de

✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000005445

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Canada, Taiwan, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

Class I 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

108listed device types

Class I 88Class II 20Class III 0

plus 109 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

163registered device records

Class I 139Class IIa 20Class IIb 4

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

2registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

24active device licences

Class II 24

30 including historic records

TWTaiwanTFDA

18valid device licences

Class I 9Class II 9

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

15active registrations

Class 2a 13Class 2b 1Class 3 1

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 Union2,791 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States109 registration records, 7 510(k), 0 PMA

United Kingdom163 confirmed, 0 excluded

Saudi Arabia2 confirmed, 0 excluded

Canada24 confirmed, 0 excluded

Manufacturer names merged into this page: GIMMI GMBH · Gimmi GmbH

Regulatory identity

EU manufacturer SRN: DE-MF-000005445
UK responsible person: MEDAGENT INTERNATIONAL UK LIMITED
Exhibition record: CMEF 89th (Apr 2024, Shanghai)

FDA 510(k) clearances by year

22001 · K012660

12002 · K012869

12009 · K081640

22010 · K092421

12026 · K261179

FDA listed device types

showing 8 of 108

Chisel, Surgical, Manual 1Knife, Nasal 1Stripper, Surgical 1Gag, Mouth 1Orthopedic Manual Surgical Instrument 1Fork, Tuning 1Knife, Ear 1Sound, Uterine 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04049047022534	—	Class I
EU	04049047022527	—	Class I
EU	04049047022503	—	Class I
EU	04049047022497	—	Class I
UK	36293	ABDOMINAL RETRACTOR	Class I
UK	35131	AMPUTATING KNIFE	Class I
UK	62458	ALPHAARTHRO OPEN CANULA	Class I
US	K261179	AlphaTriPart - Monopolar MIC Instruments	2026-07-22
US	K092421	ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC	2010-02-12
US	K093125	ALPHAXENON LIGHT 180 W AND 300 W	2010-01-27
SA	ME0000004426SFDAA00002	MONOPOLAR CABLE	—
SA	ME0000004425SFDAA00002	BIPOLAR CABLE	—
CA	65142	ALPHASCOPE LAPAROSCOPES	Class II
CA	65143	ALPHAQUICK HANDLES	Class II
CA	65178	ELECTRODES	Class II

GIMMI

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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