PerOssal®
Ref 03-01032Model 03-0102
PerOssal® (03-01032) is a Class III device made by OSARTIS GmbH, registered in EUDAMED on 7 Feb 2025 (Basic UDI-DI 426005688BSX00908Y) with CE/MDR certificate G70 107266 0014 valid until 19 Jun 2028, active as of 25 Oct 2026.
Active
CE MDR
Valid until
19 Jun 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426005688BSX00908Y 04260056881428 | Date7 Feb 2025 | StatusActive |
Official records
- EUDAMED public site 426005688BSX00908Y
Certificates
- G70 107266 0014 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 20 Jun 2023
- Expires
- 19 Jun 2028
Timeline
- Certificate issued EUDAMED G70 107266 0014
- Registered EUDAMED 426005688BSX00908Y
- Certificate expires EUDAMED G70 107266 0014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 03-0102, 03-01032
- Primary DI / UDI-DI
- 04260056881428
- Basic UDI-DI
- 426005688BSX00908Y
- EMDN code
- P900402 Resorbable filling and reconstruction devices
- Device class
- Class III
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000009545
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