Sealite Regular
Ref 266264
Sealite Regular (266264) is a Class IIa device made by Acteon Manufacturing, registered in EUDAMED on 11 Feb 2025 (Basic UDI-DI 376024300sealiterPY) with CE/MDR certificate 39305 valid until 24 May 2028, active as of 24 Oct 2026.
Active
CE MDR
Valid until
24 May 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number39305 | Date14 Jan 2026 | StatusActive |
Official records
- EUDAMED public site 376024300sealiterPY
Certificates
- 39305 Active
Quality management system EU MDR
- Certifier
- GMED SAS 0459
- Issued
- 14 Jan 2026
- Expires
- 24 May 2028
- Reason
- Add device or group
Timeline
- Registered EUDAMED 376024300sealiterPY
- Certificate issued EUDAMED 39305
- Certificate expires EUDAMED 39305
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 266264
- Primary DI / UDI-DI
- 03760243000911
- Basic UDI-DI
- 376024300sealiterPY
- EMDN code
- Q01010202 Root canal filling dental cements
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000007556
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