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

MD Atlas
Q-Med AB

Data from EUDAMED, last updated May 30, 2026

Restylane Eyelight

B-012137LC

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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Device characteristics

ImplantableIncorporates a medicinal product

Clinical investigations

Registered: No

Registered: No

Registered: No

Investigation number: MA-1300-14
Registered: No
Countries: Canada

Investigation number: NCT03003130
Registered: No
Countries: China

Investigation number: 31GE0308
Registered: No
Countries: China

Investigation number: NCT02432742
Registered: No
Countries: China

Investigation number: NCT02918721
Registered: No
Countries: China

Investigation number: 43CH1509
Registered: No
Countries: China

Investigation number: NCT02179736
Registered: No
Countries: China

Investigation number: 31GE0003
Registered: No
Countries: United States

Investigation number: NCT00935272
Registered: No
Countries: United States

Investigation number: NCT04154930
Registered: No
Countries: United States

Investigation number: MA-1400-01
Registered: No
Countries: United States

Investigation number: MA-1400-02
Registered: No
Countries: United States

Investigation number: NCT00797459
Registered: No
Countries: United States

Investigation number: NCT00977704
Registered: No
Countries: United States

Investigation number: NCT00765583
Registered: No
Countries: United States

Investigation number: MA-1900-02
Registered: No
Countries: United States

Investigation number: NCT02565784
Registered: No
Countries: Taiwan

Legacy certificates

Certificate number: 2021098CE01
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: DEKRA Certification B.V. (0344)
Validity: Dec 31, 2027

Certificate number: 2021098DE018
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-012137LC
Device name: Restylane Eyelight
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: Mar 30, 2026

Manufacturer & authorised representative

Manufacturer

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

Variants by status

UDI-DI variants

1 UDI-DI variant

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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 EyelightD-012137LC