ParietexTM
by Sofradim Production 3 variants
Part of a family of 29 devices: see the family page
Ref TET1208O
ParietexTM (TET1208O) is a Class III device made by Sofradim Production, registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 0763000B00003837T) with CE/MDR certificate MDR 729728 valid until 28 Jun 2031, active as of 24 Oct 2026.
Active
CE MDR
Valid until
28 Jun 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0763000B00003837T 10884521180123 | Date31 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 0763000B00003837T
Certificates
- MDR 729728 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 29 Jun 2026
- Expires
- 28 Jun 2031
Timeline
- Certificate issued EUDAMED MDR 729728
- Registered EUDAMED 0763000B00003837T
- Certificate expires EUDAMED MDR 729728
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- ParietexTM Hydrophylic 2D3D Anat. Mesh
- Model / reference
- TET1208O
- Primary DI / UDI-DI
- 10884521180123
- Basic UDI-DI
- 0763000B00003837T
- EMDN code
- P900205 Polyester surgical meshes
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000012211
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