GLICOFIL·LAC fast
by Assut Europe SpA 185 variants
Ref FR249LRAP
Active
CE MDR
Valid until
7 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0013236826 | Date26 Oct 2026 | StatusActive |
Certificates
- CSQ0013236626 Active
Quality management system EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
- CSQ0013236826 Active
Quality management system EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 26 Oct 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
- CVD0033240326 Active
Technical documentation EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 25 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Glicofil Lac Fast
- Model / Reference
- FR249LRAP
- Primary DI / UDI-DI
- 38033439426885
- Basic UDI-DI
- 8033439GLICOFLACFAST7N
- Direct Marketing DI
- 38033439426885
- EMDN Code
- H010101020201, H010101020202, H010101020203
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000018178
Other devices from Assut Europe SpA
Properties
Other properties (11)
- 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