Kaltek S.r.l.

Certificate 0425-MDR-030116-00

Rev. 00Issued

Valid until: Jan 8, 2030

Certificate 0425-MDR-030116-00 is a valid Quality assurance issued to Kaltek S.r.l. and registered in EUDAMED. Valid until January 8, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030116-00
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-030116-0000

Validity

Issued: Jan 9, 2025
Valid from: Jan 9, 2025
Valid until: Jan 8, 2030

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I19

19 scopes

Dispositivi per ginecologia e diagnostica (Medical Devices for gynecology and diagnostic)
Class I
Pennarello dermografico (Surgical Skin Marker)
Class I
ABBASSALINGUA
Class I
SPATOLA DI AYRE
Class I
SPAZZOLINO PRELIEVO ENDOCERVICALE “KITO- BRUSH”
Class I
“ENDO-TEK” SET PRELIEVO ENDOMETRIALE
Class I
“ENDO-TEK” SET PRELIEVO ENDOMETRIALE BIOPTICO
Class I
TAMPONE OVATTATO
Class I
Tampone in provetta sterile
Class I
PERFORATORE MEMBRANA AMNIOTICA
Class I
PINZETTA OMBELICALE
Class I
SPECULUM VAGINALE
Class I
ISTEROMETRO
Class I
CANNULA “KARMANN E BERKELEY”
Class I
KIT PER PAP-TEST
Class I
ENDOCURETTA
Class I
SONDA ENDOMETRIALE
Class I
ANOSCOPIO
Class I
PENNARELLO DERMOGRAFICO
Class I