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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

0200400414 — Class IIb MDD by Unolab manufacturing,…

MD Atlas
Unolab manufacturing, S.L.

EUDAMED last updated this device on Apr 9, 2025

0200400414

B-0200400414SK

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Unolab manufacturing, S.L.
UDI-DI code: D-0200400414SK
Reference / catalog number: 0200400414

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Manufacturer information

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

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Feb 24, 2025	Apr 9, 2025

Device identification

Trade name: not provided
UDI-DI code: D-0200400414SK
Basic UDI-DI: B-0200400414SK
Reference / catalog number: 0200400414
Issuing entity: EUDAMED

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sodium Hyaluronate-based buffered solution in single-dose format, designed for ocular and contact lens rewetting and lubrication.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q02030399OPHTHALMOLOGY, VISCOELASTIC 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

PSU-00168437009065000010017WOn the market PSU-00158437009065001030018ROn 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.