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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

KERADROP — Class IIa MDD by ITALDEVICE S.R.L.

MD Atlas
ITALDEVICE S.R.L.

EUDAMED last updated this device on Feb 13, 2025

KERADROP

B-ITMF26487HA70KER002K4

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ITALDEVICE S.R.L.
UDI-DI code: D-ITMF26487HA70KER002K4
Reference / catalog number: HA70KER002

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Manufacturer information

Organization name: ITALDEVICE S.R.L.
SRN: IT-MF-000026487
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW275
Cases of corneal calcification associated with the use of eye drops containing phosphates have been reported very rarely in patients with significantly damaged corneas. In case of band keratopathy or calcium deposits on the cornea, consult your specialist before using this product.

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Market distribution

Primary placement in France; available across 2 countries total.

Country	On market since	Until
FrancePrimary placement	Nov 13, 2015	Dec 31, 2028
Cyprus	Nov 13, 2015	Dec 31, 2028

Device identification

Trade name: KERADROP
UDI-DI code: D-ITMF26487HA70KER002K4
Basic UDI-DI: B-ITMF26487HA70KER002K4
Reference / catalog number: HA70KER002
Issuing entity: EUDAMED

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: sale unit 5 ml
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-ITMF26487HA70KER002K4

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

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

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Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030103-00Issued
Quality management systemNotified body: 0425Expiry: Nov 5, 2029