Playal 40
Ref INN113Model Playal 80
Active
CE MDR
Valid until
13 Nov 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number063-00-01-MDR | Date7 Sep 2026 | StatusActive |
Certificates
- 063-00-01-MDR Active
Quality management system EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 7 Sep 2026
- Expires
- 13 Nov 2029
- Reason
- Other
- 064-00-02-MDR Active
Technical documentation EU MDR
- Notified body
- ITALCERT SRL 0426
- Issued
- 7 Sep 2026
- Expires
- 13 Nov 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Playal Family
- Model / Reference
- Playal 80, INN113
- Primary DI / UDI-DI
- 08051040331311
- Basic UDI-DI
- 805104033artsyrniaci77U
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000026730
Other devices from Innate s.r.l.
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