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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

PT8538M — Class IIb MDR by AVIZOR S.A.

MD Atlas
AVIZOR S.A.

EUDAMED last updated this device on Jan 28, 2026

PT8538M

8431306AVEYEDROP02HYPRE98

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AVIZOR S.A.
UDI-DI code: 08431306085385
Reference / catalog number: PT8538M

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Manufacturer information

Organization name: AVIZOR S.A.
SRN: ES-MF-000020208
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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Dec 9, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08431306085385
Basic UDI-DI: 8431306AVEYEDROP02HYPRE98
Reference / catalog number: PT8538M
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.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

PT8806M8431306104AVHERBALAIOPEPEOn the market PT8807M8431306104AVHERBALAIOPEPEOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.