European Union Regulation
In the European Union, “CE marked” is not the same regulatory statement as “FDA approved.” CE marking follows conformity assessment under the applicable device framework; exact intended use and company roles still come from the current certificate, declaration of conformity, IFU, labeling, and EUDAMED or competent-authority records.
Review date: July 31, 2026.
Regulatory reading frame
Section titled “Regulatory reading frame”The European Commission describes notified bodies as organizations designated by Member States to perform required conformity-assessment tasks before qualifying products are placed on the market (European Commission 🔗).
On May 28, 2026, EUDAMED’s actor, UDI/device, notified-body and certificate, and market-surveillance modules became mandatory. The remaining vigilance and clinical-investigation modules are still under development (EUDAMED overview 🔗).
Product evidence map
Section titled “Product evidence map”| Product | Evidence reviewed | What it supports | Limitation |
|---|---|---|---|
| Sculptra | Galderma December 5, 2025 EU MDR announcement | MDR certification and expansion to four named body areas | Use current certificate and IFU for exact scope |
| Lanluma | Current Sinclair regional professional page | CE 1023, GANA R&D manufacturer, and intended-use wording | A commercial page does not replace certificate and IFU review |
| AestheFill | REGEN April 2021 company notice | Company-reported CE certificate milestone | Current MDR/MDD status, certificate number, and scope not established here |
| Juvelook | Italian Ministry of Health safety-notice record | Device identity and VAIM manufacturer role in an EU safety record | Does not by itself establish current CE certificate or intended use |
| Radiesse | Merz official historical CE announcements | CE milestone in 2004 and Radiesse Lidocaine CE mark in 2016 | Current exact certificate, variant, and IFU remain necessary |
| Ellansé | Current Sinclair professional page | EU intended use, CE 0344, and AQTIS Medical B.V. manufacturer | Verify exact current variant and governing IFU |
Product-specific notes
Section titled “Product-specific notes”Sculptra
Section titled “Sculptra”Galderma announced EU MDR certification on December 5, 2025 and stated that the certified scope expanded from the face to the gluteal area, posterior thighs, décolletage, and upper arms (Galderma announcement 🔗).
This EU development does not establish FDA or Korean approval for the same body areas.
Lanluma and Ellansé
Section titled “Lanluma and Ellansé”Sinclair’s current regional Lanluma page displays CE 1023 and describes Lanluma as a PLLA implant for increasing volume in depressed areas, particularly skin depressions (Sinclair Lanluma 🔗).
Sinclair’s current Ellansé page states an EU intended use for subdermal facial implantation to correct wrinkles and facial aging signs or conditions, and identifies CE 0344 and AQTIS Medical B.V. as manufacturer (Sinclair Ellansé 🔗).
Regional commercial copy may contain broader treatment discussion. Preserve the narrower intended-use statement and current IFU.
AestheFill, Juvelook, and Radiesse
Section titled “AestheFill, Juvelook, and Radiesse”REGEN reported that AestheFill and PowerFill obtained a CE certificate in April 2021 (REGEN notice 🔗). Because the notice does not supply the complete current certificate scope, use it as a company-reported milestone rather than a full 2026 regulatory record.
The Italian Ministry of Health hosts a Juvelook field-safety record received September 3, 2024 and updated December 2, 2025, identifying VAIM Co., Ltd. as manufacturer (Italian Ministry of Health 🔗). A safety notice establishes a regulatory relationship to the device; it does not by itself prove the current certificate scope.
Merz states that Radiesse received a European aesthetic CE mark in 2004 and Radiesse Lidocaine received CE marking in 2016 (Merz announcement 🔗). These dated milestones should not replace the current variant’s certificate and IFU.
EU record check
Section titled “EU record check”For a defensible current record, collect:
- Basic UDI-DI or exact device identifier
- manufacturer and EU authorized representative
- applicable MDR or legacy MDD status
- certificate number, notified body, scope, issue, and expiry dates
- declaration of conformity
- current language-specific IFU and intended use
- relevant EUDAMED and national competent-authority records
Return to the regional overview before translating an EU conformity statement into another jurisdiction.