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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

IS-TWO IMPLANT D.3.5 - L.13… — Class IIb MDR by AoN Implants

MD Atlas
AoN Implants

EUDAMED last updated this device on May 11, 2026

IS-TWO IMPLANT D.3.5 - L.13 OsTiOX IH

805626973IMPPU

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: AoN Implants
UDI-DI code: 08056269732918
Reference / catalog number: AIT35130N2000

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View device family (Basic UDI)

Manufacturer information

Organization name: AoN Implants
SRN: IT-MF-000011061
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

0425-MDR-030062-01Issued
Quality management systemNotified body: 0425Expiry: Jan 16, 2029

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 2 countries total.

Country	On market since	Until
ItalyPrimary placement	Jan 1, 2009	Still on market
Spain	Jan 1, 2025	Still on market

Device identification

Trade name: IS-TWO IMPLANT D.3.5 - L.13 OsTiOX IH
UDI-DI code: 08056269732918
Basic UDI-DI: 805626973IMPPU
Reference / catalog number: AIT35130N2000
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://aonimplants.it/IFU/
Clinical sizes: 3.5 MU50
13 MU50
EI
Classic

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056269732918

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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.

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

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