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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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HMC PREMEDICAL S.P.A.

Certificate 0425-MDR-030101-00

Rev. 00Issued
Valid until
Sep 26, 2029

Overview

Certificate number
0425-MDR-030101-00
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
04250425-MDR-030101-0000

Validity

Issued
Sep 27, 2024
Valid from
Sep 27, 2024
Valid until
Sep 26, 2029

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa6Class IIb4

10 scopes

  • Easy Flow Monitor
    Class IIb
  • Generatore Venturi CPAP Venturi CPAP Generator
    Class IIa
  • Umidificatore attivo TURBH2O Active Humidifier TURBH2O
    Class IIb
  • Sistema di Umidificazione e Circuiti Respiratori Humidification System and Respiratory Circuits
    Class IIa
  • Dispositivi Medici per N.I.V. Medical Devices for N.I.V
    Class IIa
  • Easy Flow Monitor
    Class IIb
  • Generatore Venturi CPAP / Venturi CPAP Generator
    Class IIa
  • Umidificatore attivo “TURBH2O” / Active Humidifier “TURBH2O”
    Class IIb
  • Sistema di Umidificazione e Circuiti Respiratori / Humidification System and Respiratory Circuits
    Class IIa
  • Dispositivi Medici per N.I.V. / Medical Devices for N.I.V
    Class IIa

Documents

LanguagesENIT

Manufacturer

Manufacturer
HMC PREMEDICAL S.P.A.
Manufacturer SRN
IT-MF-000029438
Manufacturer country
Italy