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Hp Vitaran

by BR Pharm Co., Ltd.

Ref Polynucleotides Intradermal gel

Active European Union

CE MDR

Valid until

10 Jul 2031

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number2026-AXVI/QS-005 Date10 Jul 2026IssuedStatusActive expires 10 Jul 2031

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-AXVI/QS-005 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Jul 2026
    Expires
    10 Jul 2031
  • 2026-AXVI/TD-005 Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    10 Jul 2026
    Expires
    10 Jul 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Polynucleotides intradermal gel
Model / Reference
Polynucleotides Intradermal gel
Primary DI / UDI-DI
08809360972758, 08809360972925, 08809360972918
Basic UDI-DI
8809360970003AQ
Direct Marketing DI
08809360972758
08809360972925
08809360972918
EMDN Code
X0303 Substances, combinations of substances, or items without an intended medical purpose intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, by a prefilled means for introduction, excluding those for tattooing – resorbable
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000027339
Authorised representative
KTR Europe GmbH DE-AR-000005685

Other devices from BR Pharm Co., Ltd.

Properties

  • Sterile
  • Animal Tissues

Other properties (11)

  • Implantable: No
  • 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