Dcont ROLL
by 77 Elektronika Műszeripari Kft
Ref D75-800100
Active
CE IVDR
Valid until
11 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberIX 1006099-1 | Date19 Mar 2026 | StatusActive |
Certificates
- IX 1006099-1 Active
Technical documentation EU IVDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 19 Mar 2026
- Expires
- 11 Feb 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Dcont ETALON
- Model / Reference
- D75-800100
- Primary DI / UDI-DI
- 05997345782171
- Basic UDI-DI
- 59973457DEK7V
- EMDN Code
- W0201060102 Blood glucose meters
- Device Class
- Class C
- EU market of registration
- Hungary
Manufacturer details
- EUDAMED SRN
- HU-MF-000004266
Other devices from 77 Elektronika Műszeripari Kft
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No