EUDAMED last updated this device on Jun 24, 2026

Tuff PRO Int. Hex Ti. Implant

B-07290108817607

On the marketClass IIb

Applicable legislation: —
Organization name: NORIS MEDICAL Ltd
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 →: 07290108817607
Reference / catalog number: NMAF3308

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.

Tuff PRO Int. Hex Ti. Implant is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by NORIS MEDICAL Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: Tuff PRO Int. Hex Ti. Implant
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 →: 07290108817607
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 →: B-07290108817607
Reference / catalog number: NMAF3308
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 IIb
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Classic 2-pieces (implant +abutment) endosseous dental implants are intended to be implanted in the maxilla and mandibula of edentulous or partially edentulous patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 3.3 MU50
8 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07290108817607

EMDN nomenclature code(s)

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

P01020101DENTAL IMPLANTS

Critical warnings

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

Do not use if package is damaged
Do not use past indicated date
Consult instructions for use

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	—	Still on market

Tuff PRO Int. Hex Ti. Implant

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI 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

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

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Manufacturer information

Certificates

Certificates covering this device

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Legacy certificates