HomeGermanyEberle GmbH & Co. KG

Eberle GmbH & Co. KG

Germany · Wurmberg · www.eberle-med.de
✓ Record-verifiedregistrations found in 7 marketsEU SRN DE-MF-000006291

This company has registrations in European Union, United States, United Kingdom, Brazil, South Korea, Israel, Russia — 7 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
1UDI-DI device records
Class IIa 1
USUnited StatesFDA openFDA
7listed device types
Class I 4Class II 3Class III 0
plus 12 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
8registered device records
Class I 1Class IIa 6Class IIb 1
BRBrazilANVISA
1registered devices
Class II 1
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
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
2active registrations
Class 2a 2
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 raw hits, 0 excluded, 1 confirmed
United States12 registration records, 1 510(k), 0 PMA, 1 excluded
United Kingdom8 confirmed, 0 excluded
Brazil1 confirmed, 2 excluded
Manufacturer names merged into this page: Eberle GmbH & Co. KG · EBERLE GMBH & CO. KG

Regulatory identity

EU manufacturer SRN
DE-MF-000006291
UK responsible person
Advena Ltd

Company information

Country
Germany
City
Wurmberg
Website
www.eberle-med.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.

Business registration

LEI
967600NXE6KK6APXPI26
Registration status
Active
Legal form
Kommanditgesellschaft (KG)
Incorporated
2002-10-15
Registration authority
Commercial Register, no. HRA 510783
Registry record updated
2025-11-20

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

FDA 510(k) clearances by year

12021 · K193608

FDA listed device types

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece 1Hearing Aid, Bone Conduction 1Arthroscope 1Orthopedic Manual Surgical Instrument 1Bur, Ear, Nose And Throat 1Accessories, Cleaning Brushes, For Endoscope 1Laryngostroboscope 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04050052000448Aggressive Meniscus Cutter 3.5Class IIa
UK36003Arthroscopy-pump P2Class IIa
UK38654Aggressive Full Radius Resector 2.0Class IIa
UK41499Aggressive Full Radius Resector 2.0Class IIa
USK193608EBERLE Shaver System C3 and Accessories2021-01-15
BR80044689047Lâminas de ShaverClass II

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