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SPORLASTIC GmbH & Co. KG

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Australia, Israel, Russia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

12listed device types

Class I 12Class II 0Class III 0

plus 12 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

7registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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.

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

United Kingdom9 confirmed, 0 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Manufacturer names merged into this page: SPORLASTIC GMBH & Co.KG · SPORLASTIC GMBH & CO. KG · Sporlastic GmbH

Regulatory identity

UK responsible person: G.P.B. Limited

Registration details (sample)

Market	Identifier	Name	Class / date
UK	36206	ACHILLO-HiT	Class I
UK	41435	NEURODYN-COMFORT	Class I
UK	41065	GENU-HiT GS	Class I
BR	80041210103	Órteses para coluna	Class I
BR	80041210104	Imobilizadores Sporlastic	Class I
BR	80041210106	Tensores Sporlastic	Class I
SA	ME0000009579SFDAA00001	Orthoses, Knee	—
SA	ME0000009579SFDAA00002	Orthoses, Elbow	—

SPORLASTIC GmbH & Co. KG

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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