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Norav Medical GmbH

Germany · Mainz Kastel · www.noravmedical.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN IL-MF-000007856

This company has registrations in European Union, United States, United Kingdom, Canada, Singapore, Australia, Hong Kong — 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

298UDI-DI device records

Class I 203Class IIa 95

USUnited StatesFDA openFDA

3listed device types

Class I 0Class II 3Class III 0

plus 12 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

5registered device records

Class I 1Class IIa 4

BRBrazilANVISA

0registered devices

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

15 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 7IIa 6IIb 1

HKHong KongMDACS

2valid listings

Class II 2

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 Union298 raw hits, 0 excluded, 298 confirmed

United States12 registration records, 6 510(k), 0 PMA

United Kingdom5 confirmed, 0 excluded

Manufacturer names merged into this page: Norav Medical Inc. · NORAV MEDICAL LTD. · NORAV MEDICAL LTD · NORAV MEDICAL GMBH

Regulatory identity

EU manufacturer SRN: IL-MF-000007856
EU authorised representative: Norav Medical GmbH
UK responsible person: Medes Ltd.

FDA 510(k) clearances by year

12000 · K000404

12002 · K012712

12008 · K080141

22011 · K110463

12016 · K161062

FDA listed device types

Electrocardiograph, Ambulatory, With Analysis Algorithm 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrocardiograph, Ambulatory (Without Analysis) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07290117200889	NRP-USB	Class IIa
EU	07290110255428	SW-NEMS-Web	Class IIa
EU	07290110258443	NR-314-T	Class IIa
EU	07290110258504	NR-1207	Class IIa
UK	35162	NR Series	Class IIa
UK	35562	ADAPT-M422-D-00-02	Class I
UK	36719	PC ECG 1200 series	Class IIa
US	K161062	NR Recorder	2016-06-13
US	K110463	PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)	2011-11-10
US	K111487	NH-301 AMBULATORY ECG ANALYSIS SOFTWARE	2011-11-10

Norav Medical 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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