Heg
by Biotekna S.R.L. Italy EUDAMED
Ref HEG00BModel HEG
EMDN Z12040113
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G464HEGTA | Date26 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- IT346595 Issued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 15 Oct 2025
- Expires
- 14 Oct 2030
Specification
- Model / Reference
- HEG, HEG00B
- Primary DI / UDI-DI
- G464HEG00B0
- Basic UDI-DI
- ++G464HEGTA
- Direct Marketing DI
- G464HEG00B0
- EMDN Code
- Z12040113 Regional plethysmographs
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000034522
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 494a77ed-6f3d-4eda-935c-c26a0f933607