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Enraf-Nonius B.V.

Netherlands · Rotterdam · www.enraf-nonius.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN NL-MF-000000429

This company has registrations in European Union, United States, United Kingdom, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 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

50UDI-DI device records

Class I 50

USUnited StatesFDA openFDA

12listed device types

Class I 3Class II 9Class III 0

plus 12 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class IIa 4

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

36registered imported devices

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

CACanadaMDALL

28active device licences

Class II 28

42 including historic records

TWTaiwanTFDA

5valid device licences

Class I 3Class II 2

SGSingaporeHSA SMDR

10device registrations

CLASS B 10

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

7valid listings

Class II 6Class III 1

ILIsraelAMAR

8registrations

RURussiaRoszdravnadzor

16active registrations

Class 1 2Class 2a 14

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 Union50 raw hits, 0 excluded, 50 confirmed

United States12 registration records, 5 510(k), 0 PMA

United Kingdom4 confirmed, 0 excluded

Saudi Arabia36 confirmed, 0 excluded

Canada28 confirmed, 0 excluded

Manufacturer names merged into this page: ENRAF-NONIUS B.V. · Enraf-Nonius B.V.

Regulatory identity

EU manufacturer SRN: NL-MF-000000429
UK responsible person: PHOENIX HEALTHCARE PRODUCTS LTD

FDA 510(k) clearances by year

12003 · K030297

12015 · K151640

12023 · K230472

22025 · K251083

FDA listed device types

showing 8 of 12

Massager, Therapeutic, Electric 1Table, Powered 1Exerciser, Powered 1Lamp, Infrared, Therapeutic Heating 1Stimulator, Muscle, Powered 1Equipment, Traction, Powered 1Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat 1Stimulator, Nerve, Transcutaneous, For Pain Relief 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08719992508082	Manumed ST	Class I
EU	08720618311412	Z-Ultimate	Class I
EU	08720618311368	Z-Ultimate	Class I
EU	08720618311351	Z-Ultimate	Class I
UK	17908	Sonopuls	Class IIa
UK	11248	Physisonic	Class IIa
UK	11248	Sonopuls	Class IIa
US	K251083	Compact II	2025-09-12
US	K243112	Curapuls 670	2025-06-25
US	K230472	Sonopuls 190	2023-10-24
SA	ME0000002612SFDAA00029	Manumed ST	—
SA	ME0000002612SFDAA00030	ManuXelect	—
CA	32671	VACOTRON 560 VACUUM UNIT	Class II
CA	32672	ENDOMED 582 ID ELECTROTHERAPY SYSTEM	Class II
CA	32673	SONOPULS 490 ULTRASOUND THERAPY UNIT	Class II