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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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MD Atlas
Documents

pfm medical hico GmbH

Certificate FI24/00000026

Rev. Issue 2Amended

Valid until: Apr 17, 2029

Overview

Certificate number: FI24/00000026
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI24/00000026Issue 2

Validity

Issued: Feb 14, 2025
Valid from: Feb 14, 2025
Valid until: Apr 17, 2029

Manufacturer

Manufacturer: pfm medical hico GmbH
Manufacturer SRN: DE-MF-000012921
Manufacturer country: Germany

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

FI24/00000026Quality management systemIssuedApr 18, 2024 → Apr 17, 2029

Scope coverage

Class IIb2

2 scopes

Z12040208 Body thermoregulation equipment
Class IIb
Hypo / hyperthermia systems, Models: HICO-Variotherm 550, HICO-Variotherm 555, HICO-Aquatherm 660.
Class IIb

Documents

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