Cellular Matrix
Ref BCT-HA-3
Cellular Matrix (BCT-HA-3) is a Class III device made by Regen Lab SA, registered in EUDAMED on 30 Jan 2023 (Basic UDI-DI B-07640138980022) with CE/MDR certificate MDR 756199 valid until 24 Apr 2028, active as of 22 Oct 2026.
Active
CE MDR CE MDD
Valid until
24 Apr 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 756199 | Date15 Jun 2026 | StatusActive |
| European Union | CE/MDD | NumberB-07640138980022 07640138980022 | Date30 Jan 2023 | StatusActive |
Official records
- EUDAMED public site B-07640138980022
Certificates
- MDR 756199 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 15 Jun 2026
- Expires
- 24 Apr 2028
- Reason
- Other
Timeline
- Registered EUDAMED B-07640138980022
- Certificate issued EUDAMED MDR 756199
- Certificate expires EUDAMED MDR 756199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade name
- Cellular MatrixCellular Matrix BCT-HA Kit
- Device name
- Cellular Matrix BCT-HA
- Model / reference
- BCT-HA-3
- Primary DI / UDI-DI
- 07640138980022
- Basic UDI-DI
- B-07640138980022, 764013898CMBCTHAM5
- EMDN code
- P900402 Resorbable filling and reconstruction devices
- Device class
- Class III
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CH-MF-000032231
- Authorised representative
- RegenLab France FR-AR-000011953
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