Plum Safety ApS

Certificate C590336

Rev. 0Issued

Valid until: Sep 18, 2030

Certificate C590336 is a valid Quality management system issued to Plum Safety ApS and registered in EUDAMED. Valid until September 18, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: C590336
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5903360

Validity

Issued: Sep 19, 2025
Valid from: Sep 19, 2025
Valid until: Sep 18, 2030

Manufacturer

Manufacturer: Plum Safety ApS
Manufacturer SRN: DK-MF-000008672
Manufacturer country: Denmark

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

Intended purpose: Sterile first aid product that rinses and irrigates the dirt, dust, liquid and foreign body from wounds and eyes.
Class IIb
Intended purpose: Sterile first aid product for wounds and eyes irrigation involving accidents with acids and alkali.
Class IIb
Plum Wound and Eyewash 0.9% Sodium Chloride
Class IIb
Plum Wound and Eyewash pH Neutral 4.9% Phosphate
Class IIb

Documents

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