# Puravelle

> Active: European Union. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/puravelle-deep>
- Manufacturer: [BNC KOREA, Inc.](https://devicerts.com/manufacturers/bnc-korea-inc) (South Korea)
- Name in the registry: PURAVELLE
- Device class: Class III (EU MDR)
- EMDN: 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

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 880936909BNC001H8 · UDI-DI 08809369095991 · registered 2026-10-14 · status: Active

## EU certificates

- 2026-AXVI/QS-006 · Quality management system · MDR · notified body 3EC International a.s. · issued 2026-10-06 · expires 2028-01-09 · status: issued
- 2026-AXVI/TD-006 · Technical documentation · MDR · notified body 3EC International a.s. · issued 2026-10-06 · expires 2028-01-09 · status: issued

## Recalls

No recall on record.

## Identity

- Device name: Cross-linked Hyaluronic Acid Dermal Filler with Lidocaine [EUDAMED]
- Model / reference: Light [EUDAMED]; CL-S [EUDAMED]; CL-Aqua-s [EUDAMED]; CL-Aqua [EUDAMED]; VITAL [EUDAMED]; L-LITE [EUDAMED]; HYDRO 2.0 [EUDAMED]; Aqua [EUDAMED]; AQUA PRIME [EUDAMED]; CLASSIC [EUDAMED]; CL-N [EUDAMED]; PLUS 1 [EUDAMED]; \#1 [EUDAMED]; L-KISS [EUDAMED]; SOFT [EUDAMED]; FINE [EUDAMED]; 1.0 [EUDAMED]; DRH [EUDAMED]; CLASSICUM [EUDAMED]; DEEP [EUDAMED]; CL-Max [EUDAMED]; PLUS 2 [EUDAMED]; \#2 [EUDAMED]; L-MAX [EUDAMED]; 2.0 [EUDAMED]; HYPO [EUDAMED]; Volume [EUDAMED]; CL-Max 1400 [EUDAMED]; Sub-Q [EUDAMED]; PLUS 3 [EUDAMED]; \#3 [EUDAMED]; 3.0 [EUDAMED]; CONTOUR [EUDAMED]; ENDO [EUDAMED]; CL-Ultra [EUDAMED]; CL-Strong [EUDAMED]; PURAVELLE DEEP [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 08809369095991 [EUDAMED]
- Basic UDI-DI: 880936909BNC001H8 [EUDAMED]
- EMDN code: X0303 [EUDAMED]

## Classification

- Device class: Class III [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Germany [EUDAMED]

## Properties

- Supplied sterile: Yes [EUDAMED]
- Implantable: Yes [EUDAMED]
- Incorporates a medicinal substance: Yes [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]

## Source and citation

- Cite as: Puravelle, BNC KOREA, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/puravelle-deep (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/puravelle-deep.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/puravelle-deep
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.