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Sle Limited

United Kingdom of Great Britain and Northern Ireland · South Croydon

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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

pendingnot queried

USUnited StatesFDA openFDA

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

2active device licences

Class II 1Class III 1

11 including historic records

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

10active ARTG entries

Class I 3IIa 2IIb 5

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

5active registrations

Class 2a 1Class 2b 4

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 States0 registration records, 2 510(k), 0 PMA

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: SLE LTD.

Market	Identifier	Name	Class / date
US	K011842	SABRE COMPAC	2002-01-08
US	K993177	SABRE	1999-11-16
CA	88078	SLE1000 CPAP THERAPY SYSTEM	Class II
CA	88675	SLE INFANT VENTILATOR SYSTEM	Class III

Sle Limited

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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