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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

NP70APP001 — Class IIb MDD by ITALDEVICE S.R.L.

MD Atlas
ITALDEVICE S.R.L.

EUDAMED last updated this device on Mar 26, 2025

NP70APP001

B-ITMF26487NP70APP0012M

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: ITALDEVICE S.R.L.
UDI-DI code: D-ITMF26487NP70APP0012M
Reference / catalog number: NP70APP001

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View device family (Basic UDI)

Manufacturer information

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

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Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

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

CW275
If symptoms persist, consult your eye specialist.

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Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 12, 2018	Dec 31, 2028
Austria	Dec 12, 2018	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-ITMF26487NP70APP0012M
Basic UDI-DI: B-ITMF26487NP70APP0012M
Reference / catalog number: NP70APP001
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: 10 ml OSD bottle
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-ITMF26487NP70APP0012M

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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