Joimax GmbH

Certificate G10 049319 0007

Rev. Rev. 06Supplemented

Valid until: Jan 31, 2029

Overview

Certificate number: G10 049319 0007
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 049319 0007Rev. 06

Validity

Issued: Aug 27, 2025
Valid from: Aug 27, 2025
Valid until: Jan 31, 2029

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
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: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

G10 049319 0007SupplementedMay 4, 2025 → Jan 30, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa5Class IIb3

8 scopes

Z120190 - VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY
Class IIa
Z120114 - SURGICAL NAVIGATION INSTRUMENTS
Class IIa
Z120202 - MOTORISED INSTRUMENTS FOR ENDOSCOPIC SURGERY
Class IIa
Z120109 - ELECTROSURGICAL INSTRUMENTS
Class IIb
K020199 - MONO- AND BIPOLAR DEVICES, SINGLE USE - OTHER
Class IIb
P090799 - SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER
Class IIb
Z121305 - MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS
Class IIa
V901699 - SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER
Class IIa

Documents

LanguagesEN

Joimax GmbH

Certificate G10 049319 0007

Rev. Rev. 06Supplemented

Valid until: Jan 31, 2029

Overview

Certificate number: G10 049319 0007
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 049319 0007Rev. 06

Validity

Issued: Aug 27, 2025
Valid from: Aug 27, 2025
Valid until: Jan 31, 2029

Manufacturer

Manufacturer: Joimax GmbH
Manufacturer SRN: DE-MF-000009201
Manufacturer country: Germany

Notified body

Notified body: TÜV SÜD Product Service GmbH
Notified body SRN: 0123
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: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

G10 049319 0007SupplementedMay 4, 2025 → Jan 30, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa5Class IIb3

8 scopes

Z120190 - VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY
Class IIa
Z120114 - SURGICAL NAVIGATION INSTRUMENTS
Class IIa
Z120202 - MOTORISED INSTRUMENTS FOR ENDOSCOPIC SURGERY
Class IIa
Z120109 - ELECTROSURGICAL INSTRUMENTS
Class IIb
K020199 - MONO- AND BIPOLAR DEVICES, SINGLE USE - OTHER
Class IIb
P090799 - SPINAL PROSTHESES AND STABILISATION SYSTEMS - OTHER
Class IIb
Z121305 - MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS
Class IIa
V901699 - SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER
Class IIa

Documents

LanguagesEN