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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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Phibio GmbH

Certificate 1TD-MDR-0076/10/2025

Rev. 01Issued
Valid until
Oct 1, 2028

Overview

Certificate number
1TD-MDR-0076/10/2025
Certificate type
Technical documentation
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
27641TD-MDR-0076/10/202501

Validity

Issued
Feb 25, 2026
Valid from
Feb 25, 2026
Valid until
Oct 1, 2028

Manufacturer

Manufacturer
Phibio GmbH
Manufacturer SRN
DE-MF-000045435
Manufacturer country
Germany

Notified body

Notified body
Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
Notified body SRN
2764
Notified body country
Türkiye

Characteristics

Sterile
—
Human tissues
—
Animal tissues
—
In vitro diagnostics
—
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
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

Unspecified2

2 scopes

  • Sterile Hyaluronic Acid Intra-Articular Gel Implant
    42509062IALSQ
  • Sterile Hyaluronic Acid Intra-Articular Gel Implant
    42509062IACS6

Documents

LanguagesEN

Covered devices

  • Sterile Hyaluronic Acid Intra-Articular Gel ImplantClass III
    42509062IALSQ
  • Sterile Hyaluronic Acid Intra-Articular Gel ImplantClass III
    42509062IACS6