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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

PSU-0016 — Class IIb MDR by Unolab manufacturing,…

MD Atlas
Unolab manufacturing, S.L.

EUDAMED last updated this device on May 12, 2026

PSU-0016

8437009065000010017W

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unolab manufacturing, S.L.
UDI-DI code: 08437009065099
Reference / catalog number: PSU-0016

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Manufacturer information

Organization name: Unolab manufacturing, S.L.
SRN: ES-MF-000000272
Manufacturer status: Active

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Critical warnings

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

CW135
EUDAMED did not publish a description for this code.
CW999
This product is preservative-free. After opening the unit dose, use immediately and discard after use to avoid the risk of contamination, which might lead to infection.
CW999
Do not use the product after the expiry date.
CW999
Do not use if the unit dose is damaged or accidentally opened before use.
CW999
One unit dose may only be used for one person.
CW999
Not for injection.
CW999
The same unit dose must not be used to treat eyes and nostrils at the same time.
CW999
Do not use at the same time as other products without first checking with your doctor.
CW999
Do not use on or near open wounds, as the product could cause itching, irritation or burning sensation.

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Apr 30, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437009065099
Basic UDI-DI: 8437009065000010017W
Reference / catalog number: PSU-0016
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: Sterile, preservative-free isotonicsolution in single-dose format,designed for nasal irrigation andocular rewetting, as well as forthe maintenance of contactlenses.
Additional information URL: http://unolab.es/assets-v2/FICAE2603261.pdf
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

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.