Haxl One
by i+Med S.Coop. Spain EUDAMED
Ref PV00035, PV00039Model HAXLONE (FR), HAXLONE (PL) EMDN P900402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08437015992747 | Date24 May 2024 | StatusActive |
| European Union | CE/MDD | NumberB-08437015992747 | Date24 May 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR, CE/MDD Active
Certificates
- 2026 DR 0071 Issued
Technical documentation EU MDR
- Notified body
- Notified body 0318
- Issued
- 5 Feb 2026
- Expires
- 26 Jun 2029
Specification
- Device Name
- HaxloneViscosuplemento intraarticular entrecruzado (LBTRA)
- Model / Reference
- HAXLONE (FR), PV00035, HAXLONE (PL), PV00039
- Primary DI / UDI-DI
- 08437015992747, 08437015992754
- Basic UDI-DI
- B-08437015992747, B-08437015992754, 8437015992TR00782
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- FrancePoland
Manufacturer details
- EUDAMED SRN
- ES-MF-000008633
Other devices from i+Med S.Coop.
Properties & raw data
Show properties, registry sources and raw records
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
Sources (4)
- EUDAMED e4103804-7bc3-4d26-9062-c2ee66a0af8c
- EUDAMED 08437015992754|B-08437015992754
- EUDAMED 08437015992754|8437015992TR00782
- EUDAMED 08437015992747|8437015992TR00782