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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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Organization name
UDI-DI code
Reference / catalog number

8056138130098 — Class IIb MDR by FB Dermatology S.r.l.

MD Atlas
FB Dermatology S.r.l.

EUDAMED last updated this device on Mar 3, 2026

8056138130098

805613813LUMIHEAL5G

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FB Dermatology S.r.l.
UDI-DI code: 08056138130098
Reference / catalog number: 8056138130098

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View device family (Basic UDI)

Manufacturer information

Organization name: FB Dermatology S.r.l.
SRN: IT-MF-000019037
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 3 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Poland		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056138130098
Basic UDI-DI: 805613813LUMIHEAL5G
Reference / catalog number: 8056138130098
Issuing entity: GS1

Classification

Risk category: Class IIb
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056138130098

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M0409DRESSINGS FOR PHOTO- AND THERMOTHERAPY IN THE FORM OF GELS AND SOLUTIONS

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

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Related devices

8056138130203805613813LUMIHEAL5GOn the market

Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030096-00Issued
Quality management systemNotified body: 0425Expiry: Sep 29, 2029