HomeGermanyadvanced fiber tools GmbH

advanced fiber tools GmbH

Germany · Mittweida · www.advanced-fiber-tools.de
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, United Kingdom — 2 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 2
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 Union1,528 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States1 registration records, 0 510(k), 0 PMA, 19 excluded
United Kingdom2 confirmed, 7 excluded
Brazil0 confirmed, 2 excluded
Manufacturer names merged into this page: ADVANCED FIBER TOOLS GMBH

Regulatory identity

UK responsible person
OMC MEDICAL Ltd

Company information

Country
Germany
City
Mittweida
Website
www.advanced-fiber-tools.de
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)Components (MedTech, Manufacturing, etc.)

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

Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
UK62600Ball Tip Fiber EVLAExpert BallClass IIa
UK47785Lumenis Pulseline200Class IIa

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