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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Restylane Defyne — 1 UDI-DI variant, MDD (Q-Med AB)

MD Atlas
Q-Med AB

Data from EUDAMED, last updated May 30, 2026

Restylane Defyne

B-012095LM

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class III

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: Q-Med AB

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UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KPTE78BA176XMCY2FB6AWESE

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Restylane DefyneD-012095LM

Device characteristics

ImplantableIncorporates a medicinal product

Clinical investigations

Registered: No

Registered: No

Registered: No

Registered: No

Investigation number: NCT01205061
Registered: No
Countries: United States

Investigation number: NCT02718040
Registered: No
Countries: Canada

Investigation number: NCT02672644
Registered: No
Countries: Canada

Investigation number: NCT03003130
Registered: No
Countries: China

Investigation number: NCT03967444
Registered: No
Countries: Canada

Investigation number: NCT03624816
Registered: No
Countries: United States

Investigation number: NCT03597256
Registered: No
Countries: China

Investigation number: NCT04520997
Registered: No
Countries: United States, Brazil

Registered: No

Legacy certificates

Certificate number: 2021098CE13
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: DEKRA Certification B.V. (0344)
Validity: Dec 31, 2027

Certificate number: 2021098DE24
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: DEKRA Certification B.V. (0344)
Validity: Dec 31, 2027

Identity & classification

Basic UDI-DI: B-012095LM
Device name: Restylane Defyne
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Apr 22, 2026

Manufacturer & authorised representative

Manufacturer

Name: Q-Med AB
SRN: SE-MF-000008549
Country: Sweden
Email: info.q-med@galderma.com

Variants by status