EUDAMED last updated this device on May 26, 2026

690NA418

++D748MOUNTINDEVLL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOTEC S.R.L.
UDI-DI code: +D748690NA41805
Reference / catalog number: 690NA418

690NA418 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by BIOTEC S.R.L.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Country
Date of registration
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EUDAMED last updated this device on May 26, 2026

690NA418

++D748MOUNTINDEVLL

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOTEC S.R.L.
UDI-DI code: +D748690NA41805
Reference / catalog number: 690NA418

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: +D748690NA41805
Basic UDI-DI: ++D748MOUNTINDEVLL
Reference / catalog number: 690NA418
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+D748690NA41805

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

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EMDN nomenclature code(s)

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

Z12119099VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

Device identification

Trade name: not provided
UDI-DI code: +D748690NA41805
Basic UDI-DI: ++D748MOUNTINDEVLL
Reference / catalog number: 690NA418
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 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.

Manufacturer information

Organization name: BIOTEC S.R.L.
SRN: IT-MF-000026774
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+D748690NA41805

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

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

Z12119099VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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

Certificates

Certificate health across this manufacturer's portfolio.

007-00-06-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Dec 20, 2027
008-00-04-MDRSupplemented
Technical documentationNotified body: 0426Expiry: Dec 20, 2027
088-00-00-MDRIssued
Quality management systemNotified body: 0426Expiry: Dec 18, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by BIOTEC S.R.L.

Market distribution

Primary placement in Italy; available across 32 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

690NA418

690NA418

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

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