Phytopharm Klęka S.A.

Certificate C08 PL042103 2606

Rev. Rev.00Issued

Valid until: Jun 15, 2031

Certificate C08 PL042103 2606 is a valid Quality management system issued to Phytopharm Klęka S.A. and registered in EUDAMED. Valid until June 15, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: C08 PL042103 2606
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2803C08 PL042103 2606Rev.00

Validity

Issued: Jun 16, 2026
Valid from: Jun 16, 2026
Valid until: Jun 15, 2031

Manufacturer

Manufacturer: Phytopharm Klęka S.A.
Manufacturer SRN: PL-MF-000042103
Manufacturer country: Poland

Notified body

Notified body
Notified body SRN: 2803
Notified body country: Cyprus

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Fiorda spray
Class IIa
Fiorda Max MD
Class IIa

Documents

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