heracure 3D
Ref 5220189Model Block
Active
CE MDR
Valid until
1 Jun 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIZ 1037386-1 | Date8 Sep 2025 | StatusActive |
Certificates
- HZ 1037386-1 Active
Quality management system EU MDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 2 Jun 2023
- Expires
- 1 Jun 2028
- IZ 1037386-1 Active
Technical documentation EU MDR
- Certifier
- TÜV Rheinland LGA Products GmbH 0197
- Issued
- 8 Sep 2025
- Expires
- 1 Jun 2028
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- INNOTERE 3D Scaffold
- Model / Reference
- Block, 5220189
- Primary DI / UDI-DI
- +EINN5220189
- Basic UDI-DI
- ++EINNCPFK9C
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000006515
Other devices from INNOTERE GmbH
Properties
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