BK Medical ApS

Certificate 10000449961-PA-NoMA-DNK

Rev. 3Issued

Valid until: Jul 17, 2027

Certificate 10000449961-PA-NoMA-DNK is a valid Quality management system issued to BK Medical ApS and registered in EUDAMED. Valid until July 17, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000449961-PA-NoMA-DNK
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000449961-PA-NoMA-DNK3

Validity

Issued: Jul 18, 2022
Valid from: Jul 18, 2022
Valid until: Jul 17, 2027

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb6Class I2

8 scopes

[The 2300 Ultrasound System (bk3000/bk5000/bkActiv/bkActiv S series) is a multipurpose mobile, software-controlled diagnostic Ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The system is used in the following areas of application: Abdominal, Cardiac Adult, Fetal (incl.Obstetrics), Neonatal Cephalic, Adult Cephalic (Transcranial), Transrectal, Transvaginal, Small Organs (Small parts), Peripheral Vessel
Class IIb
Sterile single use needle guide
Class I
bkSpecto Ultrasound System 1300 is a multi-purpose mobile, softwarecontrolled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas of application: Urology, Anaesthesia
Class IIb
+The 5P1e is a surface transducer intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Class IIb
2300 Ultrasound Systems (bk3000/bk5000/bkActiv/bkActiv S series)
Class IIb
Sterile-single use Needle guide UA1338
Class I
bkSpecto Ultrasound System 1300
Class IIb
5P1e Transducer 9087
Class IIb

Documents

LanguagesEN

Scope coverage

Class IIb6Class I2

8 scopes

[The 2300 Ultrasound System (bk3000/bk5000/bkActiv/bkActiv S series) is a multipurpose mobile, software-controlled diagnostic Ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The system is used in the following areas of application: Abdominal, Cardiac Adult, Fetal (incl.Obstetrics), Neonatal Cephalic, Adult Cephalic (Transcranial), Transrectal, Transvaginal, Small Organs (Small parts), Peripheral Vessel
Class IIb
Sterile single use needle guide
Class I
bkSpecto Ultrasound System 1300 is a multi-purpose mobile, softwarecontrolled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms.The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas of application: Urology, Anaesthesia
Class IIb
+The 5P1e is a surface transducer intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
Class IIb
2300 Ultrasound Systems (bk3000/bk5000/bkActiv/bkActiv S series)
Class IIb
Sterile-single use Needle guide UA1338
Class I
bkSpecto Ultrasound System 1300
Class IIb
5P1e Transducer 9087
Class IIb

Certificate 10000449961-PA-NoMA-DNK

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Certificate 10000449961-PA-NoMA-DNK

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer