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Puravelle

by BNC KOREA, Inc. 4 variants

Part of a family of 102 devices: see the family page

Ref PURAVELLE DEEPModel Light,CL-S,CL-Aqua-s,CL-Aqua,VITAL,L-LITE,HYDRO 2.0,Aqua,AQUA PRIME,CLASSIC,CL-N,PLUS 1,#1,L-KISS,SOFT,FINE,1.0,DRH,CLASSICUM,DEEP,CL-Max,PLUS 2,#2,L-MAX, 2.0,HYPO, Volume,CL-Max 1400,Sub-Q,PLUS 3,#3,3.0,CONTOUR,ENDO,CL-Ultra,CL-Strong

PURAVELLE DEEP is a medical device (EU MDR Class III; EMDN category substances) made by BNC KOREA, Inc., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 880936909BNC001H8), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

9 Jan 2028

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number880936909BNC001H8 Basic UDI-DI 08809369095991UDI-DIDate14 Oct 2026RegisteredStatusActive

Official records

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2026-AXVI/QS-006 Active

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    6 Oct 2026
    Expires
    9 Jan 2028
  • 2026-AXVI/TD-006 Active

    Technical documentation EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    6 Oct 2026
    Expires
    9 Jan 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Cross-linked Hyaluronic Acid Dermal Filler with Lidocaine
Model / reference
Light, CL-S, CL-Aqua-s, CL-Aqua, VITAL, L-LITE, HYDRO 2.0, Aqua, AQUA PRIME, CLASSIC, CL-N, PLUS 1, #1, L-KISS, SOFT, FINE, 1.0, DRH, CLASSICUM, DEEP, CL-Max, PLUS 2, #2, L-MAX, 2.0, HYPO, Volume, CL-Max 1400, Sub-Q, PLUS 3, #3, 3.0, CONTOUR, ENDO, CL-Ultra, CL-Strong, PURAVELLE DEEP
Primary DI / UDI-DI
08809369095991
Basic UDI-DI
880936909BNC001H8
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
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000008321
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

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 BNC KOREA, Inc.

See all devices from BNC KOREA, Inc. →

Properties

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