Hedia ApS

Certificate G10 105438 0004

Rev. Rev. 00Issued

Valid until: Jul 7, 2029

Certificate G10 105438 0004 is a valid Quality management system issued to Hedia ApS and registered in EUDAMED. Valid until July 7, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 105438 0004
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 105438 0004Rev. 00

Validity

Issued: Jul 8, 2024
Valid from: Jul 8, 2024
Valid until: Jul 7, 2029

Manufacturer

Manufacturer: Hedia ApS
Manufacturer SRN: DK-MF-000013969
Manufacturer country: Denmark

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

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 IIb1

1 scope

Z129092 - VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
Class IIb

Documents

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