HomeGermanyAMNOTEC International Medical GmbH

AMNOTEC International Medical GmbH

Germany · Neuhausen ob Eck · www.amnotec.de
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, 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
0UDI-DI device records
USUnited StatesFDA openFDA
119listed device types
Class I 106Class II 13Class III 0
plus 126 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
96registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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 States126 registration records, 0 510(k), 0 PMA
Saudi Arabia96 confirmed, 0 excluded
Manufacturer names merged into this page: AMNOTEC INTERNATIONAL MEDICAL GMBH · AMNOTEC International Medical GmbH

Company information

Country
Germany
City
Neuhausen ob Eck
Website
www.amnotec.de
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentSurgical systems & instruments

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

showing 8 of 119
Knife, Nasal 1Halter, Head, Traction 1Clamp, Rubber Dam 1Gag, Mouth 1Chisel, Bone, Surgical 1Sound, Uterine 1Syringe, Irrigating (Non Dental) 1Clamp, Penile 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000001335SFDAA00002AMNOLED Examination Lights
SAME0000001342SFDAA00001AMNOTABLE COMPACT

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