Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

PSU-0015 — Class IIb MDR by Unolab manufacturing,…

MD Atlas
Unolab manufacturing, S.L.

EUDAMED last updated this device on May 13, 2026

PSU-0015

8437009065001030018R

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Unolab manufacturing, S.L.
UDI-DI code: 08437009065082
Reference / catalog number: PSU-0015

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Critical warnings

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

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 in one person.
CW999
Not for injection.
CW999
Wetting Solution contains a level of Boric Acid that is safe when used according to label instructions.
CW999
Do not use jointly with other products without first checking with your doctor.
CW999
Do not use the product if you are allergic to any of its ingredients.
CW999
Do not use on or near open wounds, as the product could cause itching, irritation or a burning sensation.
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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 13, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437009065082
Basic UDI-DI: 8437009065001030018R
Reference / catalog number: PSU-0015
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: Sodium Hyaluronate-basedbuffered solution in single-doseformat, designed for ocular andcontact lens rewetting andlubrication.
Additional information URL: http://unolab.es/assets-v2/IEAHA0403261.pdf
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030301OPHTHALMOLOGY, HYALURONIC ACID AND DERIVATIVES

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

0200400414B-0200400414SKOn the market PSU-00168437009065000010017WOn the market PSU-00138437009065001030018ROn 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.