BtHCROSS 2.0%
by i+Med S.Coop. Spain EUDAMED
Ref PV00030Model BtHCROSS 2.0%, FILLAH MEDIUM 1.75%, FILLAH INTENSE 2.0%, HAXL ONE, Harmonie 2% EMDN P900402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08437015992082 | Date29 Nov 2023 | StatusActive |
| European Union | CE/MDD | NumberB-08437015992082 | Date29 Nov 2023 | 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- Withdrawn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
- Trade Name
- BtHCROSS 2.0%Haxl One
- Device Name
- BtHCROSSViscosuplemento intraarticular entrecruzado (LBTRA)
- Model / Reference
- BtHCROSS 2.0%, PV00030, FILLAH MEDIUM 1.75%, FILLAH INTENSE 2.0%, HAXL ONE, Harmonie 2%
- Primary DI / UDI-DI
- 08437015992082, 08437027750038, 08437027750045, 08437027750397, 08428991000762
- Basic UDI-DI
- B-08437015992082, B-08437027750038, B-08437027750045, B-08437027750397, B-08428991000762, 8437015992TR00782
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- SpainFrance
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 (6)
- EUDAMED 49475de5-acaa-4007-bebd-c1e97d689fdb
- EUDAMED 08437027750038|B-08437027750038
- EUDAMED 08437027750045|B-08437027750045
- EUDAMED 08437027750397|B-08437027750397
- EUDAMED 08428991000762|B-08428991000762
- EUDAMED 08437027750397|8437015992TR00782