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Cellular Matrix

by Regen Lab SA 2 variants

Ref BCT-HA-1

Cellular Matrix (BCT-HA-1) is a Class III device made by Regen Lab SA, registered in EUDAMED on 30 Jan 2023 (Basic UDI-DI B-07640138981463) with CE/MDR certificate MDR 756199 valid until 24 Apr 2028, active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

24 Apr 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 756199 Date15 Jun 2026IssuedStatusActive expires 24 Apr 2028
European UnionCE/MDD NumberB-07640138981463 Basic UDI-DI 07640138981463UDI-DIDate30 Jan 2023RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 756199 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    15 Jun 2026
    Expires
    24 Apr 2028
    Reason
    Other

Timeline

3 dated events

  1. Registered EUDAMED B-07640138981463
  2. Certificate issued EUDAMED MDR 756199
  3. Certificate expires EUDAMED MDR 756199

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Trade name
Cellular Matrix
Cellular Matrix BCT-HA Kit
Device name
Cellular Matrix BCT-HA
Model / reference
BCT-HA-1
Primary DI / UDI-DI
07640138981463
Basic UDI-DI
B-07640138981463, 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

Similar devices in this category

Other devices filed under RESORBABLE FILLING AND RECONSTRUCTION DEVICES.

Other devices from Regen Lab SA

See all devices from Regen Lab SA →

Properties

  • Supplied sterile
  • Implantable
Other properties (12, all answered No)