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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

TC Fidelis 3.5x8 drill — Class IIa MDR by MOZO GRAU SA

MD Atlas
MOZO GRAU SA

EUDAMED last updated this device on May 25, 2026

TC Fidelis 3.5x8 drill

84354826FIDELISDRILLSXF

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MOZO GRAU SA
UDI-DI code: 08435482642417
Reference / catalog number: 21803508

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View device family (Basic UDI)

Manufacturer information

Organization name: MOZO GRAU SA
SRN: ES-MF-000009479
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Spain; available across 3 countries total.

Country	On market since	Until
SpainPrimary placement		Still on market
Poland		Still on market
Romania		Still on market

Device identification

Trade name: TC Fidelis 3.5x8 drill
UDI-DI code: 08435482642417
Basic UDI-DI: 84354826FIDELISDRILLSXF
Reference / catalog number: 21803508
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: TICARE DENTAL FIDELIS DRILLS OF TICARE DENTAL IMPLANT SYSTEM
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)08435482642417

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UDI-PI DataMatrix

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

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EMDN nomenclature code(s)

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

L159007ODONTOSTOMATOLOGY BURS, REUSABLE

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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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.