Leniref chewable tablets
Ref PEGRLENI0001Model TABLETS
Leniref chewable tablets (PEGRLENI0001) is a Class III device made by PHARMA LINE Srl, registered in EUDAMED on 28 May 2026 (Basic UDI-DI 805826596FT007MDRTABLET9E), active as of 7 Nov 2026.
Active
CE MDR
Valid until
22 Apr 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805826596FT007MDRTABLET9E 08058265962399 | Date28 May 2026 | StatusActive |
Official records
- EUDAMED public site 805826596FT007MDRTABLET9E
Certificates
- 095-00-00-MDR Active
Technical documentation EU MDR
- Certifier
- ITALCERT SRL 0426
- Issued
- 23 Apr 2026
- Expires
- 22 Apr 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Leniref Tablets
- Model / reference
- TABLETS, PEGRLENI0001
- Primary DI / UDI-DI
- 08058265962399
- Basic UDI-DI
- 805826596FT007MDRTABLET9E
- EMDN code
- G0401 Orally administered devices for the therapy of gastro-intestinal disorders
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Greece
Manufacturer details
- EUDAMED SRN
- IT-MF-000032122
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