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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

i-system Abutment Handle — Class I MDR by Novodent SA

MD Atlas
Novodent SA

EUDAMED last updated this device on May 21, 2024

i-system Abutment Handle

763018820003BX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Novodent SA
UDI-DI code: 07630188205596
Reference / catalog number: I-SAH

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View device family (Basic UDI)

Manufacturer information

Organization name: Novodent SA
SRN: CH-MF-000023309
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

No critical warnings reported for this device.

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Market distribution

Primary placement in Türkiye; available across 1 country total.

Country	On market since	Until
TürkiyePrimary placement	Sep 28, 2023	Still on market

Device identification

Trade name: i-system Abutment Handle
UDI-DI code: 07630188205596
Basic UDI-DI: 763018820003BX
Reference / catalog number: I-SAH
Issuing entity: GS1

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: i-system Abutment Handle
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

EMDN nomenclature code(s)

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

P01020180DENTAL IMPLANTS - ACCESSORIES

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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