Spellman High Voltage Electronics GmbH

Certificate FI25/00000027

Rev. Issue 1Issued

Valid until: Apr 3, 2030

Certificate FI25/00000027 is a valid Quality management system issued to Spellman High Voltage Electronics GmbH and registered in EUDAMED. Valid until April 3, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI25/00000027
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI25/00000027Issue 1

Validity

Issued: Apr 4, 2025
Valid from: Apr 4, 2025
Valid until: Apr 3, 2030

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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 IIb5

5 scopes

Z11039011 – High voltage X-ray generators
Class IIb
Medical X-Ray Generator Models: EDITOR HFe 401 alternative names: PROVARIO HF 40, OptiX 40 HF
Class IIb
Medical X-Ray Generator Models: EDITOR HFe 501 alternative names: PROVARIO HF 50, OptiX 50 HF
Class IIb
Medical X-Ray Generator Models:EDITOR HFe 601 alternative names: PROVARIO HF 60, OptiX 60 HF
Class IIb
Medical X-Ray Generator Models:EDITOR HFe 801 alternative names: PROVARIO HF 80, OptiX 80 HF
Class IIb

Documents

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