Healthy.io

Certificate D1417700028

Amended

Valid until: Sep 20, 2029

Certificate D1417700028 is a valid Quality management system issued to Healthy.io and registered in EUDAMED. Valid until September 20, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: D1417700028
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0483D1417700028

Validity

Issued: Jun 8, 2026
Valid from: Jun 8, 2026
Valid until: Sep 20, 2029

Manufacturer

Manufacturer: Healthy.io
Manufacturer SRN: IL-MF-000023029
Manufacturer country: Israel

Notified body

Notified body
Notified body SRN: 0483
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: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Amended

Supersedes

D1417700024IssuedSep 1, 2025 → Sep 20, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class C1

1 scope

Biochemical tests for screening, determination or monitoring of physiological markers for a specific disease
IVDR Class C

Documents

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