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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

Hain Lifescience GmbH

Certificate V70 079456 0011

Rev. Rev. 00Issued

Valid until: Jan 27, 2030

Overview

Certificate number: V70 079456 0011
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V70 079456 0011Rev. 00

Validity

Issued: Jan 28, 2025
Valid from: Jan 28, 2025
Valid until: Jan 27, 2030

Manufacturer

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
Manufacturer country: Germany

Notified body

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

Covered devices

GENERIC HIV-1 VIRAL LOAD VER 2.0IVDR Class D
40490550300001105U6

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

GENERIC HIV-1 VIRAL LOAD VER 2.0
40490550300001105U6

Documents

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