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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

Dr. Müller Pharma s.r.o.

Certificate 2023-MDR/QS-033/B

Rev. 2Supplemented

Valid until: Oct 20, 2028

Overview

Certificate number: 2023-MDR/QS-033/B
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652023-MDR/QS-033/B2

Validity

Issued: May 2, 2025
Valid from: May 2, 2025
Valid until: Oct 20, 2028

Manufacturer

Manufacturer: Dr. Müller Pharma s.r.o.
Manufacturer SRN: CZ-MF-000000005
Manufacturer country: Czechia

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Supplemented

Supersedes

2023-MDR/QS-033/AQuality management systemSupplementedOct 20, 2024 → Oct 20, 2028

Scope coverage

Class IIb2

2 scopes

Vaginal devices in the form of solutions/creams/ova/tablets
Class IIb
DEVICE
Class IIb

Documents

LanguagesCSEN

Covered devices

Vaginální gel s kyselinou hyaluronovouClass IIb
85956104VGHAYC