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Organization name
UDI-DI code
Reference / catalog number

PV00045 — Class IIa MDD by i+Med S.Coop.

MD Atlas
i+Med S.Coop.

EUDAMED last updated this device on Nov 30, 2023

PV00045

B-08437015992150

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: i+Med S.Coop.
UDI-DI code: 08437015992150
Reference / catalog number: PV00045

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Manufacturer information

Organization name: i+Med S.Coop.
SRN: ES-MF-000008633
Manufacturer status: Active

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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.

Critical warnings

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

CW275
Consult your doctor, pharmacist or optician before using the product during pregnancy or breast-feeding.
CW276
Do not use with other products containing quaternary ammonium salts such as benzalkonium chloride because sodium hyaluronate may precipitate in its presence. After using DAYDROP, wait at least 15 minutes to apply any other product or medicine to the eye. DAYDROP is compatible with contact lenses . After putting on the contact lenses and before applying the drops, it is recommended to wait about 30 minutes to avoid incompatibility reactions between the products used for the maintenance of contact lenses and DAYDROP.
CW999
Do not administer DAYDROP if you have hypersensitivity to hyaluronic acid or other components of the product. Do not use if you are allergic to any ingredient. Do not touch your eye, or any surface with the tip of the product vial. Do not share the product with other people. May cause temporary blurring immediately after using the drops. Wait for clear vision before carrying out risky activities. For external use only, do not ingest.
CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW032
Do not use the product after the expiration date indicated on the box or on the packaging.
CW007
EUDAMED did not publish a description for this code.
CW277
Contact your doctor or pharmacist if you notice any side effects related to using DAYDROP. lf these effects persist or worsen, consult your doctor or pharmacist.
CW135
Keep out of the sight and reach of children. Use with caution in pediatric population (product not evaluated in children).

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Sep 29, 2020	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437015992150
Basic UDI-DI: B-08437015992150
Reference / catalog number: PV00045
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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
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Software identification