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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

5010097 — Class III MDR by Alfa Intes Industria…

MD Atlas
Alfa Intes Industria Terapeutica Splendore S.r.l.

EUDAMED last updated this device on Feb 28, 2025

5010097

805848137IDROFLOGAM

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Alfa Intes Industria Terapeutica Splendore S.r.l.
UDI-DI code: 08058481370060
Reference / catalog number: 5010097

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View device family (Basic UDI)

Manufacturer information

Organization name: Alfa Intes Industria Terapeutica Splendore S.r.l.
SRN: IT-MF-000025980
Manufacturer status: Active

Critical warnings

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

CW264
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Nov 15, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08058481370060
Basic UDI-DI: 805848137IDROFLOGAM
Reference / catalog number: 5010097
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: 15 vials of 0,5 ml
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)08058481370060

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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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Related devices

5010110805848137IDROFLOGAMOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CVD0028240125Supplemented
Technical documentationNotified body: 0373Expiry: Jun 13, 2029
CSQ0023240225Supplemented
Quality management systemNotified body: 0373Expiry: Jun 13, 2029