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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

EMDN-EUDAMED+DYNA — Class III MDD by OPKO HEALTH SPAIN S.L.U.

MD Atlas
OPKO HEALTH SPAIN S.L.U.

EUDAMED last updated this device on Apr 7, 2022

EMDN-EUDAMED+DYNA

B-08414042001628

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OPKO HEALTH SPAIN S.L.U.
UDI-DI code: 08414042001628
Reference / catalog number: EMDN-EUDAMED+DYNA

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Manufacturer information

Organization name: OPKO HEALTH SPAIN S.L.U.
SRN: ES-MF-000014342
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08414042001628
Basic UDI-DI: B-08414042001628
Reference / catalog number: EMDN-EUDAMED+DYNA
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: ID: 3578 Categoria: Q EMDN code: Q02030206 Level: 5 EYE LUBRICANT SOLUTIONS
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

EMDN- EUDAMED + DYNAB-08414042001062On the market EMDN- EUDAMED + DYNAB-08414042003264On the market EMDN- EUDAMED + DYNAB-08414042001574On the market EMDN- EUDAMED + DYNAB-08414042005169On the market EMDN- EUDAMED + DYNAB-08414042003509On 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.