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Organization name
UDI-DI code
Reference / catalog number

10621700BGTRRUAZ — Class IIb MDR by FB VISION S.p.A.

MD Atlas
FB VISION S.p.A.

EUDAMED last updated this device on Mar 3, 2026

10621700BGTRRUAZ

805116070FT701LumixaEJ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: FB VISION S.p.A.
UDI-DI code: 08051160700004
Reference / catalog number: 10621700BGTRRUAZ

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View device family (Basic UDI)

Manufacturer information

Organization name: FB VISION S.p.A.
SRN: IT-MF-000020083
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030111-00Issued
Quality management systemNotified body: 0425Expiry: Dec 18, 2029
IT328004Issued
Quality management systemNotified body: 1370Expiry: Dec 19, 2028

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Bulgaria; available across 2 countries total.

Country	On market since	Until
BulgariaPrimary placement	Mar 3, 2026	Still on market
Türkiye	Mar 3, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08051160700004
Basic UDI-DI: 805116070FT701LumixaEJ
Reference / catalog number: 10621700BGTRRUAZ
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)08051160700004

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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.

Q02030206EYE LUBRICANT 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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