Albomed GmbH

Certificate D1478800025

Supplemented

Valid until: Apr 20, 2031

Certificate D1478800025 is a valid Quality management system issued to Albomed GmbH and registered in EUDAMED. Valid until April 20, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: D1478800025
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0483D1478800025

Validity

Issued: Jun 10, 2026
Valid from: Jun 10, 2026
Valid until: Apr 20, 2031

Manufacturer

Manufacturer: Albomed GmbH
Manufacturer SRN: DE-MF-000007875
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0483
Notified body country: Germany

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

D1478800023ReissuedApr 21, 2026 → Apr 20, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III13

13 scopes

ArsyVisc 1.6% 2.0 ml ArsyVisc 2.2% 2.0 ml ArsyVisc 2.5% 3.0 ml ArsyVisc 2.5% 4.8 ml
Class III
PRONOLIS HD Mini 1.0% PRONOLIS HD Mini 1.6% PRONOLIS HD One 2.2% PRONOLIS HD Mono 2.5%
Class III
RECOSYN® forte N RECOSYN® m.d. N RECOSYN® uno ultra
Class III
Synsons Mini 1.0 Synsons 1.0 Synsons+ Mini 1.6 Synsons+ 1.6 Synsons Xtra 2.2 Solo 120 2.5
Class III
Flexotron Ultra Flexotron Solo Flexotron Smart Flexotron Classic Flexotron Mini Flexotron Mini Plus Flexotron Ultra M
Class III
Hyalumax Artimax Articu
Class III
OArt+ 10 OArt+ 32 OArt+ 44 OArt+ 120
Class III
9G-Visc 1.6% IA 2.0 ml 9G-Visc 2.2% IA 2.0 ml
Class III
KD Intra-Articular Gel 1.0% 1.0 ml KD Intra-Articular Gel 1.0% 2.0 ml KD Intra-Articular Gel 1.6% 1.0 ml KD Intra-Articular Gel 1.6% 2.0 ml KD Intra-Articular Gel 2.2% 1.0 ml KD Intra-Articular Gel 2.2% 2.0 ml KD Intra-Articular Gel 2.5% 2.0 ml KD Intra-Articular Gel One 2.5% 3.0 ml KD Intra-Articular Gel Ultra One 2.5% 4.8 ml
Class III
EasyVadin 1.0% 1.0 ml EasyVadin 1.0% 2.0 ml EasyVadin 1.6% 1.0 ml EasyVadin 1.6% 2.0 ml EasyVadin 2.2% 2.0 ml EasyVadin 2.5% 3.0 ml EasyVadin 2.5% 4.8 ml
Class III
GOaktiv INJEKT 1.0% GOaktiv INJEKT MINI 1.0% GOaktiv INJEKT HIGH 1.6% GOaktiv INJEKT PLUS 2.2% GOaktiv INJEKT ONE 2.5% GOaktiv INJEKT ONE MAX 2.5%
Class III
SYNOZ 1.0% SYNOZ START 1.0% SYNOZ PLUS 1.6% SYNOZ XF 2.2% SYNOZ ULTRA 2.5%
Class III
JointVisc 20 mg 2 ml JointVisc Forte 1.6% JointVisc Plus 2.2% JointVisc One 2.5%
Class III

Documents

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