EUDAMED last updated this device on Jul 16, 2026

NemoStudio

8437023642NemotecSB

On the marketClass IIa

Applicable legislation: —
Organization name: Software Nemotec S.L.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08437023642085
Reference / catalog number: 25.0.0.3

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

NemoStudio is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Software Nemotec S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: NemoStudio
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08437023642085
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 8437023642NemotecSB
Reference / catalog number: 25.0.0.3
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: NemoStudio is a suite of modules that allows import/ capture, storage, analysis, treatment plan and presenting/reporting of all those patients and their records. Device Description: NemoStudio offers a complete pack of modules for the dental industry which can be added according to the customer’s needs and desired features. Each module is adapted to a different field of service, as follows: NemoCast: Software for Orthodontic diagnosis and planning. NemoCAD: The software NemoCAD is intended to be used at an adequate dental clinic or a dental laboratory. NemoCeph: Cephalometric Software. NemoFAB: Software for Orthognathic surgery. NemoFAB Ortho: Software for Orthognathic surgery (only preparation of NemoFAB without osteotomies) NemoScan: Software for Implantology diagnosis and planning. NemoSmile: Software for Digital Smile Design.
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

Encoded

(01)08437023642085

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Critical warnings

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

Consultar warnings, contraindicaciones y precauciones en el manual de usuario del producto, se encuentra en la plataforma NemoUniversity de Nemotec. Consulte con su técnico o gestor si no puede acceder a él una vez adquirido el producto.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 8 countries total.

Country	On market since	Until
SpainPrimary placement	Jul 15, 2026	Jul 15, 2039
Belgium	Jul 16, 2026	Jul 15, 2039
Germany	Jul 16, 2026	Jul 15, 2039
France	Jul 16, 2026	Jul 15, 2039
Ireland	Jul 16, 2026	Jul 15, 2039
Italy	Jul 16, 2026	Jul 15, 2039
Malta	Jul 16, 2026	Jul 15, 2039
Portugal	Jul 16, 2026	Jul 15, 2039

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: NemoStudio
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 08437023642085
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: 8437023642NemotecSB
Reference / catalog number: 25.0.0.3
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Device details

Quantity: 1
Additional product description: NemoStudio is a suite of modules that allows import/ capture, storage, analysis, treatment plan and presenting/reporting of all those patients and their records. Device Description: NemoStudio offers a complete pack of modules for the dental industry which can be added according to the customer’s needs and desired features. Each module is adapted to a different field of service, as follows: NemoCast: Software for Orthodontic diagnosis and planning. NemoCAD: The software NemoCAD is intended to be used at an adequate dental clinic or a dental laboratory. NemoCeph: Cephalometric Software. NemoFAB: Software for Orthognathic surgery. NemoFAB Ortho: Software for Orthognathic surgery (only preparation of NemoFAB without osteotomies) NemoScan: Software for Implantology diagnosis and planning. NemoSmile: Software for Digital Smile Design.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Critical warnings

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

Consultar warnings, contraindicaciones y precauciones en el manual de usuario del producto, se encuentra en la plataforma NemoUniversity de Nemotec. Consulte con su técnico o gestor si no puede acceder a él una vez adquirido el producto.
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Spain; available across 8 countries total.

Country	On market since	Until
SpainPrimary placement	Jul 15, 2026	Jul 15, 2039
Belgium	Jul 16, 2026	Jul 15, 2039
Germany	Jul 16, 2026	Jul 15, 2039
France	Jul 16, 2026	Jul 15, 2039
Ireland	Jul 16, 2026	Jul 15, 2039
Italy	Jul 16, 2026	Jul 15, 2039
Malta	Jul 16, 2026	Jul 15, 2039
Portugal	Jul 16, 2026	Jul 15, 2039

NemoStudio

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Certificates

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