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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

HippoCreates bv

Certificate 21M00015CRT03

Amended

Valid until: Dec 2, 2029

Overview

Certificate number: 21M00015CRT03
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 191221M00015CRT03

Validity

Issued: May 14, 2025
Valid from: May 14, 2025
Valid until: Dec 2, 2029

Manufacturer

Manufacturer: HippoCreates bv
Manufacturer SRN: BE-MF-000002106
Manufacturer country: Belgium

Notified body

Notified body: Kiwa Assurance B.V.
Notified body SRN: 1912
Notified body country: Netherlands

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: No
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

21M00015CRT02Quality management systemIssuedDec 2, 2024 → Dec 2, 2029

Scope coverage

Class IIa2

2 scopes

MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation
Class IIa
S.P.A.T (Skin Prick Automated Test)
Class IIa

Documents

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