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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

860628 — Class IIb MDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Aug 27, 2025

860628

37603160095160125GOBGOIV6

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678606286
Reference / catalog number: 860628

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Manufacturer information

Organization name: BIOSYNEX
SRN: FR-MF-000014073
Manufacturer status: Active

Critical warnings

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

CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW315
EUDAMED did not publish a description for this code.
CW999
Do not ingest
CW999
Do not use with another eye solution
CW999
Do not use the product continuously for more than 28 consecutive days
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03532678606286
Basic UDI-DI: 37603160095160125GOBGOIV6
Reference / catalog number: 860628
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: GOUTTES FORMULE INCOLORE 10 ML IT
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - OTHER

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

Related devices

1120001-50353267F00074P8GOn the market 860045B-05400606954236On the market AMAZON BASIC CARE VAGINAL INFECTIONS TESTB-05400606954229On the market 1090003B-03700531705135On the market 1090003_CB-03532670103684On the market

Certificates

Certificate health across this manufacturer's portfolio.

030/MDRIssued
Quality management systemNotified body: 0051Expiry: Jun 5, 2027
G10 002187 0009Issued
Quality management systemNotified body: 0123Expiry: Sep 25, 2028