HomeUSAMED-Fibers, Inc

MED-Fibers, Inc

USA · Chandler AZ · www.med-fibers.com
✓ Record-verifiedregistrations found in 5 marketsEU SRN US-MF-000039524

This company has registrations in European Union, United States, United Kingdom, Taiwan, Australia — 5 overseas markets. EU UDI-DI records ≥73, 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
≥73UDI-DI device records
Class IIb 73
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIb 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
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
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 Union315 raw hits, 227 excluded, 73 confirmed. Large result set — only the first 300 verified
United States3 registration records, 1 510(k), 0 PMA, 3 excluded
United Kingdom2 confirmed, 1 excluded
Manufacturer names merged into this page: MED-FIBERS, INC.

Regulatory identity

EU manufacturer SRN
US-MF-000039524
EU authorised representative
Total-Laser Solution GmbH
UK responsible person
QARA Business Solutions Ltd

Company information

Country
USA
City
Chandler AZ
Website
www.med-fibers.com
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 510(k) clearances by year

12013 · K124003

FDA listed device types

Dislodger, Stone, Basket, Ureteral, Metal 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
EU00855950006295MED-Fibers, Inc. Class IIb
EU10865325000114MED-Fibers, Inc. Class IIb
EU10865325000107MED-Fibers, Inc. Class IIb
EU10855950006797MED-Fibers, Inc. Class IIb
UK61474Surgical Laser Fiber, reuseableClass IIb
UK62600Surgical Laser Fiber, single-useClass IIb
USK124003MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE2013-01-17

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