HomeSlovakiaCHIRANA T. Injecta, a.s.

CHIRANA T. Injecta, a.s.

Slovakia · Stara Tura · www.vitrexmg.com
✓ Record-verifiedregistrations found in 6 marketsEU SRN SK-MF-000003702

This company has registrations in European Union, United States, United Kingdom, Australia, Israel, Russia — 6 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
226UDI-DI device records
Class I 36Class IIa 189Class IIb 1
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 4 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
6registered device records
Class I 1Class IIa 5
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
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 4Class 3 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 Union253 raw hits, 27 excluded, 226 confirmed
United States4 registration records, 6 510(k), 0 PMA
United Kingdom6 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: CHIRANA T.INJECTA, A.S.

Regulatory identity

EU manufacturer SRN
SK-MF-000003702
UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
Slovakia
City
Stara Tura
Website
www.vitrexmg.com
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
CHIRANA T.Injecta, a. s.
LEI
315700W71HBHX3V6RF50
Registration status
Active
Legal form
Akciová spoločnosť (Akc. spol.)
Incorporated
2007-06-21
Registration authority
Business Register, no. 36794619
Registry record updated
2026-05-19

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12021 · K201009
22022 · K220614
12024 · K242434
22026 · K252483

FDA listed device types

Tubes, Vials, Systems, Serum Separators, Blood Collection 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08586015046605CHIRANA 2ml Luer with needle 0,6x30mmClass IIa
EU08586015046599CHIRANA 2ml Luer with needle 0,6x25mmClass IIa
EU08586015047138CHIRANA 20ml Luer with needle 1,2x40mmClass IIa
EU08586015043369CHIRANA 20ml Luer with needle 0,9x40mmClass IIa
UK44127cleanFINEClass IIa
UK59040STERILE ENTERAL SYRINGE FOR SINGLE USEClass I
UK47017STERILE HYPODERMIC SYRINGE FOR SINGLE USEClass IIa
USK252483Enteral Syringe (20ml, 60ml)2026-07-01
USK252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)2026-04-17
USK242434Insulin Syringes2024-12-24

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