Afta Lacer Advanced Spray 20 ml
by FARMACEUTICI PROCEMSA S.p.A Società Benefit
Ref 1131307
Active
CE MDR
Valid until
25 Jun 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 00016-A | Date24 Jun 2026 | StatusActive |
Certificates
- MDR 00016-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 24 Jun 2026
- Expires
- 25 Jun 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Apthe spray
- Model / Reference
- 1131307
- Primary DI / UDI-DI
- 08430340068668
- Basic UDI-DI
- 8002395procemsaaphte3BL
- EMDN Code
- Q01010399 Dental medication devices - other
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- IT-MF-000047492
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Properties
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