MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

  • MD Atlas
  • Documents

Bisico GmbH

Certificate 7531GB448231219

Issued
Valid until
Dec 8, 2027

Overview

Certificate number
7531GB448231219
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
04827531GB448231219

Validity

Issued
Dec 19, 2023
Valid from
Dec 19, 2023
Valid until
Dec 8, 2027

Notified body

Notified body
DNV MEDCERT GmbH
Notified body SRN
0482
Notified body country
Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
No
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
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa7

7 scopes

  • MDN 1103 EMDN Q0101
    Class IIa
  • MDN 1103 EMDN Q0102
    Class IIa
  • MDN 1209 EMDN Q0101
    Class IIa
  • MDN 1209 EMDN Q0102
    Class IIa
  • MDN 1209 EMDN Q0105
    Class IIa
  • MDN 1214 EMDN Q0304
    Class IIa
  • MDN 1204 EMDN Z121390
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Bisico GmbH
Manufacturer SRN
DE-MF-000005871
Manufacturer country
Germany