GiPSEweb (mobile)
by Dedalus Italia SpA Italy EUDAMED
Ref GiPSEweb (mobile), GiPSEweb (Mobile)Model ER4H FirstAid Web EMDN V92
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805572803ER4HDK | Date13 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 00290-A Issued
Quality management system EU MDR
- Notified body
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 31 Jan 2026
- Expires
- 15 Nov 2027
Specification
- Device Name
- ER4H FirstAid Web
- Model / Reference
- ER4H FirstAid Web, GiPSEweb (mobile)
- Primary DI / UDI-DI
- 08055728030893, 08055728031135
- Basic UDI-DI
- 805572803ER4HDK
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIb
- Special Device Type
- Software
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000009127
Other devices from Dedalus Italia SpA
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 (2)
- EUDAMED 931197f6-ebc5-4a42-aac4-8bd8fb461c91
- EUDAMED 08055728031135|805572803ER4HDK