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Core Fill Plus

by YURIM MEDICAL Co., Ltd. 4 variants

Ref CORE FILL PLUS FINEModel CORE FILL PLUS

CORE FILL PLUS FINE is a medical device (EU MDR Class III; EMDN category substances) made by YURIM MEDICAL Co., Ltd., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 880968473961COREFILLBS) with CE/MDR certificate 2026-AXVI/QS-004 valid until 25 Jun 2031, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

25 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier 3EC International a.s.

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880968473961COREFILLBS Basic UDI-DI 08809684749135UDI-DIDate29 Jun 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-AXVI/QS-004 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    25 Jun 2026
    Expires
    25 Jun 2031
  • 2026-AXVI/TD-004 Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    25 Jun 2026
    Expires
    25 Jun 2031

Timeline

5 dated events

  1. Certificate issued EUDAMED 2026-AXVI/QS-004
  2. Certificate issued EUDAMED 2026-AXVI/TD-004
  3. Registered EUDAMED 880968473961COREFILLBS
  4. Certificate expires EUDAMED 2026-AXVI/QS-004
  5. Certificate expires EUDAMED 2026-AXVI/TD-004

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
CORE FILL PLUS, CORE FILL PLUS FINE
Primary DI / UDI-DI
08809684749135
Basic UDI-DI
880968473961COREFILLBS
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 registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009011
Authorised representative
SOAR & PARTNERS Sp. z o.o. PL-AR-000040956

Similar devices in this category

Other devices filed under 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.

Other devices from YURIM MEDICAL Co., Ltd.

See all devices from YURIM MEDICAL Co., Ltd. →

Properties

  • Supplied sterile
  • Implantable
  • Incorporates a medicinal substance
Other properties (11, all answered No)