Tengeer
by Gpi S.P.A. Italy EUDAMED
Ref TENGEER
EMDN Z11069092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT321284 | Date9 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- IT321284 Supplemented
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 9 May 2025
- Expires
- 22 Feb 2028
- Reason
- Add device or group
- IT321284 Reissued
Quality management system EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 23 Feb 2023
- Expires
- 22 Feb 2028
Specification
- Model / Reference
- TENGEER
- Primary DI / UDI-DI
- 80589461100406
- Basic UDI-DI
- 805894611TENGEER2BJ
- EMDN Code
- Z11069092 Various digital bioimaging management instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000020127
Other devices from Gpi S.P.A.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 472ea6a0-f2dc-405c-9680-bad1dbf68a36