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Joline GmbH & Co. KG

Germany · Hechingen · www.joline.de

✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000005494

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Hong Kong, Israel, Russia — 8 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

8UDI-DI device records

Class I 6Class III 2

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 2 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

15registered device records

Class I 1Class IIa 12Class III 1System or Procedure Pack 1

BRBrazilANVISA

8registered devices

Class II 8

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 1Class 2b 2

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 Union8 raw hits, 0 excluded, 8 confirmed

United States2 registration records, 1 510(k), 0 PMA

United Kingdom15 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: JOLINE GMBH & CO. KG · JOLINE GMBH CO. KG · JOLINE GMBH

Regulatory identity

EU manufacturer SRN: DE-MF-000005494
UK responsible person: Advena Ltd

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04250203936118	—	Class I
EU	04250203931793	—	Class I
EU	04250203943475	QuattroMix	Class I
EU	04250203943444	QuattroMix	Class I
UK	47129	Access Kit	System or Procedure Pack
UK	11330	BONE DRILL	Class IIa
UK	60478	RapidIntro Vertebra Introducer Device, Bevel Tip	Class IIa
US	K192449	Joline Kyphoplasty System Allevo	2020-05-27
BR	10289680201	Conjunto de cânulas para cifoplastia Smart Kit Allevo	Class II
BR	10289689013	Cureta Allevo - S9410	Class II
BR	10289680202	Conjunto de cânulas para cifoplastia Stop'n Go Speed Track Smart Kit A	Class II

Joline GmbH & Co. KG

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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