Certificates & Standards
Podima Medikal is accredited with internationally recognized certifications and independent test reports, proving our commitment to quality, safety, and sustainability.
EU 2016/745 Medical Device Regulation Certificates
- CE 0425 – Notified Body Certified (Medical Device)
Certified under the European Union Medical Device Regulation (MDR 2017/745)
EU 2016/425 PPE Regulation Certificates
- Module B: SV 100 - 190
- Module C2: SV 100 C2 - 190 C2
Compliance with EU regulations from design to production, with continuous monitoring.
International Certifications
- ECO Label
- FDA Certification
- OEKO-TEX STANDARD 100
- ISO 9001, 14001, 45001
- ISO 10002, 13485
Verified compliance with global quality, safety, and sustainability standards.
Test Reports
- BUTEKOM EN1149
- EKOTEKS
Independent accredited lab reports confirming performance & safety.
