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Enko Prp+ha

by Regen Lab SA

Ref EK-PRPHA-3

Enko Prp+ha (EK-PRPHA-3) is a Class III device made by Regen Lab SA, registered in EUDAMED on 10 Jun 2024 (Basic UDI-DI 764013898CMACPHAL6) with CE/MDR certificate MDR 756198 valid until 24 Apr 2028, active as of 25 Oct 2026.

Active European Union

CE MDR

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 756198 Date15 Jun 2026IssuedStatusActive expires 24 Apr 2028

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 756198 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 764013898CMACPHAL6
  2. Certificate issued EUDAMED MDR 756198
  3. Certificate expires EUDAMED MDR 756198

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Cellular Matrix A-CP-HA
Model / reference
EK-PRPHA-3
Primary DI / UDI-DI
07640138980145
Basic UDI-DI
764013898CMACPHAL6
EMDN code
P900402 Resorbable filling and reconstruction devices
Device class
Class III
EU registration type
Standard device
EU market of registration
Spain

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.

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Properties

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