Osteomesh
by Osteopore International Pte Ltd 4 variants
Part of a family of 132 devices: see the family page
Ref PC11(25,10,1)
Osteomesh (PC11(25,10,1)) is a Class III device made by Osteopore International Pte Ltd, registered in EUDAMED on 26 Jun 2023 (Basic UDI-DI 888501320PCOSXL8) with CE/MDR certificate IZ 2068842-1 valid until 24 Apr 2028, active as of 22 Oct 2026.
Active
CE MDR
Valid until
24 Apr 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number888501320PCOSXL8 08885013200201 | Date26 Jun 2023 | StatusActive |
Official records
- EUDAMED public site 888501320PCOSXL8
Certificates
- IZ 2068842-1 Active
Technical documentation EU MDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 8 May 2023
- Expires
- 24 Apr 2028
Timeline
- Certificate issued EUDAMED IZ 2068842-1
- Registered EUDAMED 888501320PCOSXL8
- Certificate expires EUDAMED IZ 2068842-1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Germany
- Greece
- Italy
- Portugal
- Slovenia
- Spain
- Türkiye
Specification
- Device name
- Osteopore PCL Scaffold
- Model / reference
- PC11(25, 10, 1)
- Primary DI / UDI-DI
- 08885013200201
- Basic UDI-DI
- 888501320PCOSXL8
- EMDN code
- P900402 Resorbable filling and reconstruction devices
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Portugal
Manufacturer details
- EUDAMED SRN
- SG-MF-000011857
- Authorised representative
- Obelis s.a. BE-AR-000000106
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