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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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INNOTERE GmbH

Certificate HZ 1037386-1

Rev. Rev.0Issued
Valid until
Jun 1, 2028

Certificate HZ 1037386-1 is a valid Quality management system issued to INNOTERE GmbH and registered in EUDAMED. Valid until June 1, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
HZ 1037386-1
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 1037386-1Rev.0

Validity

Issued
Jun 2, 2023
Valid from
Jun 2, 2023
Valid until
Jun 1, 2028

Notified body

Notified body
TÜV Rheinland LGA Products GmbH
Notified body SRN
0197
Notified body country
Germany

Characteristics

Sterile
No
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
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

  • P900402 - Structures Filling, Replacement and Reconstruction Devices, Resorbable Fillng and Reconstration Devices
    Class III
  • DEVICE
    Class III

Documents

LanguagesEN

Manufacturer

Manufacturer
INNOTERE GmbH
Manufacturer SRN
DE-MF-000006515
Manufacturer country
Germany

Covered devices

  • INNOTERE 3D ScaffoldClass III
    ++EINNCPFK9C