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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

Vulkan® External Hex. NP Implant… — Class IIb MDR

MD Atlas
TITANIMPLANT, S.L.

EUDAMED last updated this device on Dec 3, 2025

Vulkan® External Hex. NP Implant 3.30x08

84355392011TA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TITANIMPLANT, S.L.
UDI-DI code: 08435539233247
Reference / catalog number: EXT3308

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Manufacturer information

Organization name: TITANIMPLANT, S.L.
SRN: ES-MF-000003263
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.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jul 17, 2023	Still on market
Italy	Jul 17, 2023	Still on market

Device identification

Trade name: Vulkan® External Hex. NP Implant 3.30x08
UDI-DI code: 08435539233247
Basic UDI-DI: 84355392011TA
Reference / catalog number: EXT3308
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.titanimplant.net/instrucciones-uso/
Clinical sizes: 3.3 MU50
8 MU50

EMDN nomenclature code(s)

P01020101DENTAL IMPLANTS

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

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification