The CE marking four-digit number that is displayed next to the CE mark on some medical devices is the Notified Body (NB) number. If there is no CE marking four-digit number, this means that the medical device is a Class I device that does not require NB involvement (i.e., self-declaration).
Is UL a notified body?
Under Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), UL has taken the decision to restrict its designation as a Notified Body. Under the IVDD, UL will be limiting its scope under the IVDD to a single NBOG code, IVD 0308 (Risk of trisomy 21 (incl.
Which notified body has the ID number 0482?
MEDCERT ZERTIFIZIERUNGS
List of Notified bodies accredited for Medical Device CE Marking
| NB Number | Notified Body Name | Country |
|---|---|---|
| NB 0482 | MEDCERT ZERTIFIZIERUNGS | Germany |
| NB 0483 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Germany |
| NB 0494 | SLG PRUF UND ZERTIFIZIERUNGS GMBH | Germany |
| NB 0499 | SOCIETE NATIONALE DE CERTIFICATION ET D HOMOLOGATION S.A.R.L. (SNCH) | Luxembourg |
What is TÜV SÜD Notified Body number?
A CE marking followed by a four-digit identification number indicates that a Notified Body was involved in conformity assessment. CE 0123 shows that TÜV SÜD was the Notified Body involved in conformity assessment. Many consumers take the CE marking as a sign that a product is in conformity with the relevant directives.
What is a Notified Body?
A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states.
What is notified body CE marking?
Notified Body – Medical Device CE Marking. A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate.
What is the identification number for the medical device safety program?
Our identification number is 0482. We are a team of dedicated professionals. Our goal is to ensure patient safety and provide medical device manufacturers and subcontractors an efficient and applied approach to certification. We continuously update our expertise, abilities and competence.
What is medical device CE marking audit?
Medical device CE Marking consists of two stage audit. Generally the stage one audit is offsite – depends on the device’s intended use and risk. Stage two audit is performed at the facility against ISO 13485 compliance. Audit duration and number of auditors are determined by the notified body based on device class and risk involved.
