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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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BIOTRONIK SE & Co. KG

Certificate 13290GB450230504A

Issued
Valid until
Feb 20, 2028

Certificate 13290GB450230504A is a valid Technical documentation issued to BIOTRONIK SE & Co. KG and registered in EUDAMED. Valid until February 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
13290GB450230504A
Certificate type
Technical documentation
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
048213290GB450230504A

Validity

Issued
May 4, 2023
Valid from
May 4, 2023
Valid until
Feb 20, 2028

Notified body

Notified body
DNV MEDCERT GmbH
Notified body SRN
0482
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

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

  • Device
    4035479BUDI00021PS

Documents

LanguagesEN

Manufacturer

Manufacturer
BIOTRONIK SE & Co. KG
Manufacturer SRN
DE-MF-000005049
Manufacturer country
Germany

Covered devices

  • 4035479BUDI00021PSClass III
    4035479BUDI00021PS

Linked SSCPs

  • SSCP EUDAMED_SCP_000-006-573