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REJURAN s (pouch)

by PharmaResearch Co., Ltd.

Ref REJURAN sModel REJURAN, REJURAN i, REJURAN s, M2-001, M2-002, M2-003

Active European Union

CE MDR

Valid until

12 Dec 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0880005100M148257G Basic UDI-DI 08800051000057UDI-DIDate3 Dec 2025RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2024-AXVI/QS-001/A Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Nov 2025
    Expires
    12 Dec 2029
  • 2024-AXVI/TD-001/A Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    11 Nov 2025
    Expires
    12 Dec 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Rejuran
Model / Reference
REJURAN, REJURAN i, REJURAN s, M2-001, M2-002, M2-003
Primary DI / UDI-DI
08800051000057
Basic UDI-DI
0880005100M148257G
Direct Marketing DI
08800051000057
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000031646
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from PharmaResearch Co., Ltd.

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No