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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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Documents

RAPID Biomedical GmbH

Certificate HZ 1419035-1

Rev. Rev. 1Reissued

Valid until: Feb 11, 2031

Overview

Certificate number: HZ 1419035-1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1419035-1Rev. 1

Validity

Issued: Feb 9, 2026
Valid from: Feb 12, 2026
Valid until: Feb 11, 2031

Manufacturer

Manufacturer: RAPID Biomedical GmbH
Manufacturer SRN: DE-MF-000008285
Manufacturer country: Germany

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
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: 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: Others

History

Supersedes

HZ 1419035-1Quality management systemIssuedDec 13, 2021 → Feb 11, 2026

Scope coverage

Class IIa1

1 scope

Z110590 - MAGNETIC RESONANCE IMAGING (MRI) INSTRUMENTS
Class IIa

Documents

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