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Organization name
UDI-DI code
Reference / catalog number

BepanthenSensicalm® Paupières — Class III MDR

MD Atlas
Bayer Consumer Care AG

EUDAMED last updated this device on Mar 27, 2026

BepanthenSensicalm® Paupières

4064273B161082100G5

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Bayer Consumer Care AG
UDI-DI code: 04064273110008
Reference / catalog number: 04064273110008

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Manufacturer information

Organization name: Bayer Consumer Care AG
SRN: CH-MF-000014141
Manufacturer status: Active

Related devices

Bepanderm®4064273B161082100G5On the market 040642731501274064273B161082100G5On the market 040642731200384064273B161082100G5On the market 040642731500664064273B161082100G5On the market 1610821B-CH-MF-000014141H9On the market

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW999
Do not use in the case of known allergies to any listed ingredient. If an allergic reaction develops, you should stop using the product. If you experience any skin reaction, discontinue use and seek medical advice if necessary. For external use only. Keep out of reach and sight of children. Choking hazard may occur with the tube cap. The product should only be used before the expiry date stated on the box. In case of direct contact with the eyes, rinse thoroughly with clean water.
CW010
EUDAMED did not publish a description for this code.
CW264
Dexpanthenol

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: BepanthenSensicalm® Paupières
UDI-DI code: 04064273110008
Basic UDI-DI: 4064273B161082100G5
Reference / catalog number: 04064273110008
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M04041503DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH SYNTHETIC COMPONENTS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

G70 054972 0038Issued
Technical documentationNotified body: 0123Expiry: Feb 17, 2030