HomeGermanyEPflex Feinwerktechnik GmbH

EPflex Feinwerktechnik GmbH

Germany · Dettingen an der Erms
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Taiwan, South Korea, Australia, Hong Kong, Israel — 8 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
6listed device types
Class I 1Class II 5Class III 0
plus 8 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
4registered device records
Class I 1Class IIa 2Class III 1
BRBrazilANVISA
17registered devices
Class II 17
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
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
4active ARTG entries
Class III 3Class Is (sterile) 1
HKHong KongMDACS
2valid listings
Class IV 2
ILIsraelAMAR
2registrations
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 States8 registration records, 0 510(k), 0 PMA
United Kingdom4 confirmed, 0 excluded
Brazil17 confirmed, 0 excluded
Manufacturer names merged into this page: EPFLEX FEINWERKTECHNIK GMBH

Regulatory identity

UK responsible person
MEDAGENT INTERNATIONAL UK LIMITED

Company information

Country
Germany
City
Dettingen an der Erms
Product categories
Software, Digitalization, Cybersecurity & Future TechnologiesRobotics

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.

Business registration

Legal name
EPflex Feinwerktechnik GmbH.
LEI
529900225ROOU3KW3V78
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1994-03-30
Registration authority
Commercial Register, no. HRB 360950
Registry record updated
2025-09-14

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

FDA listed device types

Dislodger, Stone, Basket, Ureteral, Metal 1Endoscopic Guidewire, Gastroenterology-Urology 1Wire, Guide, Catheter 1Wire, Guide, Catheter, Exempt 1Dislodger, Stone, Flexible 1Stylet, Ureteral 1

Registration details (sample)

MarketIdentifierNameClass / date
UK35094Guidewire Class III
UK46691GuidewireClass IIa
UK58115GuidewireClass IIa
BR80459130040Sonda Extratora de Cálculos TiplessClass II
BR80807430001Cesta para Extração de Cálculos EPFIexClass II
BR80807430004Fio Guia Hidrofílico EPFlexClass II

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