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SonoScape Medical Germany GmbH

Germany · Düsseldorf · www.sonoscape.de

✓ Record-verifiedregistrations found in 10 marketsEU SRN CN-MF-000009623

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong — 10 overseas markets. EU UDI-DI records ≥300, 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

≥300UDI-DI device records

Class I 38Class IIa 259Class IIb 3

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 7Class III 0

plus 52 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

30registered device records

Class I 5Class IIa 23Class IIb 2

BRBrazilANVISA

25registered devices

Class II 25

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class III 2

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

4device registrations

CLASS B 2CLASS C 2

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 3Manufacturing 1

AUAustraliaTGA ARTG

36active ARTG entries

Class I 2IIa 34

HKHong KongMDACS

6valid listings

Class II 6

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 Union938 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States52 registration records, 25 510(k), 0 PMA, 1 excluded

United Kingdom30 confirmed, 0 excluded

Brazil25 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: SONOSCAPE MEDICAL CORP. · Sonoscape Medical Corp

Regulatory identity

EU manufacturer SRN: CN-MF-000009623
EU authorised representative: Shanghai International Holding Corp. GmbH(Europe)
UK responsible person: Qserve Group UK, Ltd.

FDA 510(k) clearances by year

32015

32016

72017

12018

12019

12020

42022

12023

12024

22025

12026

FDA listed device types

Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Biopsy Needle Guide Kit 1Colonoscope And Accessories, Flexible/Rigid 1Endoscope, Accessories, Narrow Band Spectrum 1Gastroscope And Accessories, Flexible/Rigid 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06945868617226	BCC9-5	Class IIa
EU	06945868616571	SU11B CU	Class IIa
EU	06945868616564	SU11B AD	Class IIa
EU	06945868616557	SU11B PRO	Class IIa
UK	40763	Intravascular Ultrasound Diagnostic System	Class IIa
UK	64014	Single-use Distal Hood	Class I
UK	64277	Single-use Distal End Cap	Class I
US	K254028	Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)	2026-05-15
US	K252498	Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU)	2025-12-05
US	K241949	Digital Color Doppler Ultrasound System (P60 Series)	2025-01-17
BR	81464759052	Sistema de ultrassom digital com doppler colorido	Class II
BR	81464759018	Gastrovideoscópio ultrassônico	Class II
BR	81464759065	Insuflador	Class II
SA	ME0000014680SFDAA00031	Trolley	—
CA	93170	SONOSCAPE PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM	Class III
CA	93242	PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM	Class III

SonoScape Medical Germany GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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