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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

02876 — Class IIa MDD by MONTEFARMACO OTC SPA

MD Atlas
MONTEFARMACO OTC SPA

EUDAMED last updated this device on May 31, 2022

02876

B-NOKSANPOM2K

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: MONTEFARMACO OTC SPA
UDI-DI code: D-NOKSANPOM2K
Reference / catalog number: 02876

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View device family (Basic UDI)

Manufacturer information

Organization name: MONTEFARMACO OTC SPA
SRN: IT-MF-000013309
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

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

CW011
Tenere fuori dalla portata e dalla vista dei bambini. Tenere lontano da fonti di calore. Non usare in caso di ipersensibilità accertata ad uno dei componenti. Non utilizzare su pelle infiammata e su piccoli tagli o screpolature. CHiudere con cura il tubetto dopo l'uso.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 26, 2008	May 26, 2024

Device identification

Trade name: not provided
UDI-DI code: D-NOKSANPOM2K
Basic UDI-DI: B-NOKSANPOM2K
Reference / catalog number: 02876
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: NOK SAN is used for keratolysis, i.e. the elimination of hyperkeratosis, thickenings of the skin commonly called calluses
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-NOKSANPOM2K

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.

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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