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PARI GmbH

www.pari.com

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, United Kingdom, Singapore, Israel, Russia — 5 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

0UDI-DI device records

USUnited StatesFDA openFDA

8510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class I 1Class IIa 6Class IIb 2System or Procedure Pack 2

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 2Class 2a 3

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 Union3,474 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States0 registration records, 8 510(k), 0 PMA, 5 excluded

United Kingdom11 confirmed, 3 excluded

Canada0 confirmed, 1 excluded

Regulatory identity

UK responsible person: PARI Medical Ltd
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
UK	35142	PARI BABY Mask	Class IIa
UK	35457	PARI LC Family	Class IIa
UK	35457	LC SPRINT SP Adult Mask Eastern Europe	System or Procedure Pack
US	K002862	PRONEB ULTRA MODEL NUMBER 85B0100	2001-03-13
US	K983308	RC CORNET, MODEL #44F50	1999-06-04
US	K972042	PARI PEP THERAPY SYSTEM	1997-08-05

PARI GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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