Contura International A/S

Certificate G70 003953 0006

Rev. Rev. 01Supplemented

Valid until: Nov 8, 2027

Overview

Certificate number: G70 003953 0006
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G70 003953 0006Rev. 01

Validity

Issued: Dec 5, 2024
Valid from: Dec 5, 2024
Valid until: Nov 8, 2027

Manufacturer

Manufacturer: Contura International A/S
Manufacturer SRN: DK-MF-000002018
Manufacturer country: Denmark

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

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

Status changes

Supplemented

Supersedes

G70 003953 0006IssuedNov 8, 2022 → Dec 3, 2024

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified2

2 scopes

Bulkamid® Hydrogel
5704101BulkamidCG
Arthrosamid®
5704101Arthrosamid3K

Documents

LanguagesEN

Contura International A/S

Certificate G70 003953 0006

Rev. Rev. 01Supplemented

Valid until: Nov 8, 2027

Overview

Certificate number: G70 003953 0006
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G70 003953 0006Rev. 01

Validity

Issued: Dec 5, 2024
Valid from: Dec 5, 2024
Valid until: Nov 8, 2027

Manufacturer

Manufacturer: Contura International A/S
Manufacturer SRN: DK-MF-000002018
Manufacturer country: Denmark

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
Notified body country: Germany

Covered devices

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

Status changes

Supplemented

Supersedes

G70 003953 0006IssuedNov 8, 2022 → Dec 3, 2024

Predecessor certificate not registered in EUDAMED.

Scope coverage

Unspecified2

2 scopes

Bulkamid® Hydrogel
5704101BulkamidCG
Arthrosamid®
5704101Arthrosamid3K

Documents

LanguagesEN