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Sky Medical a.s.

Slovakia · Samorin · www.med-sky.com

✓ Record-verifiedregistrations found in 7 marketsEU SRN SK-MF-000001475

This company has registrations in European Union, United States, United Kingdom, Canada, Australia, Israel, Russia — 7 overseas markets. EU UDI-DI records ≥129, the first 300 verified individually. 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

≥129UDI-DI device records

Class IIa 59Class IIb 70

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 5 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 2Class IIa 6Class IIb 1

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

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 1IIb 1Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 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.

European Union2,712 raw hits, 171 excluded, 129 confirmed. Large result set — only the first 300 verified

United States5 registration records, 6 510(k), 0 PMA, 13 excluded

United Kingdom9 confirmed, 13 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 5 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SKY Medical, a.s. · SKY MEDICAL TECHNOLOGY LIMITED, ALSO TRADING AS FIRSTKIND LIMITED

Regulatory identity

EU manufacturer SRN: SK-MF-000001475
UK responsible person: Comply Express Ltd

FDA 510(k) clearances by year

12004 · K042134

12005 · K052456

12006 · K061367

12007 · K061919

12015 · K150685

12025 · K250481

FDA listed device types

Gastrointestinal Tubes With Enteral Specific Connectors 1Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	18586026085713	Physiological Pressure Transducer Sets	Class IIb
EU	18586021471023	Physiology Pressure Transducer Sets	Class IIb
EU	18586021474604	Physiology Pressure Transducer Sets	Class IIb
EU	18586021470347	Physiology Pressure Transducer Sets	Class IIb
UK	16866	Adhesive Strip	Class I
UK	46573	Neuromuscular Electro-stimulation Device	Class IIa
UK	46573	Neuromuscular Electro-stimulation Device	Class IIa
US	K250481	Extension Feeding Set with ENFit Connectors	2025-04-18
US	K150685	Skynector CPAP Mask	2015-08-24
US	K061919	VERSATILE 1 EZCARE WOUND VACUUM SYSTEM	2007-02-05

Sky Medical a.s.

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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