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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

Hydrablue — Class IIb MDR by BIOSYNEX

MD Atlas
BIOSYNEX

EUDAMED last updated this device on Aug 27, 2025

Hydrablue

37603160095160125GOBGOIV6

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOSYNEX
UDI-DI code: 03532678606347
Reference / catalog number: 860634

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Manufacturer information

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

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Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
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

Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
France		Still on market

Device identification

Trade name: Hydrablue
UDI-DI code: 03532678606347
Basic UDI-DI: 37603160095160125GOBGOIV6
Reference / catalog number: 860634
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 BLEUE DUOPACK 2x10ML 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

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