Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009212453

FEI Number

3009212453

Entity Name

ELVATION MEDICAL GMBH

City/State/Country

Kieselbronn Baden-Wurttemberg, DE

Establishment Address

Ludwig-Wolf-Str. 6, Kieselbronn Baden-Wurttemberg 75249, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

ELvation Medical GmbH (Owner Number: 10042279)

Owner / Operator Contact Address

Ludwig-Wolf-Str. 6, Kieselbronn, DE-BW 75249, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3000950 Mindray Z50 Piezolith 3000 Triple Focus PiezoWave 2 MyACT PiezoWave 2 Touch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2018-06-19
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-06-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-06-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-06-20
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	Class 2	876.5990	2023-11-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2012-11-07

Official Correspondent

Frederic Reisser

US Agent Details

Marco Ruggiero Business: ELvation Medical LLC Email: marco.ruggiero@elvationusa.com Phone: (440) 7813622

Related Public Records

Same Entity

ELvation Medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K191007	Supersonic Imagine	Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems	2019-10-25
K974588	Rimed , Ltd.	INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD	1998-08-07
K142628	Siemens Medi Cal Solutions, Inc.	Acuson SC2000 Diagnostic Ultrasound System	2014-10-10
K132171	Supersonic Imagine	AIXPLORER	2013-09-24
K222441	Bk Medical Aps	Ultrasound System 2300	2022-12-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022	FujiFilm Healthcare Americas Corporation	2	Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024	FUJIFILM Healthcare Americas Corporation	2	Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

Similar Registrations

Registration Number	Establishment Name	Location
3030194752	ZHEJIANG FEIMAN MEDICAL TECHNOLOGY CO., LTD	Jiaxing City Zhejiang, CN
3023449169	BEIJING ROSSUMROBOT TECHNOLOGY CO., LTD.	Beijing, CN
3003900596	SCHAERER MEDICAL AG	Muensingen Bern, CH
3008388379	Mizuho (Thailand) Co., Ltd.	Bang Pa-In Phra Nakhon Si Ayutthaya, TH
3011547624	MIZUHO CORPORATION	BUNKYO-KU Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009212453. Last updated year: 2026. Please use registration number 3009212453 when referencing this establishment in official correspondence.