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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

20902403 — Class I MDR by ORTHOKEY ITALIA SRL

MD Atlas
ORTHOKEY ITALIA SRL

EUDAMED last updated this device on Apr 22, 2026

20902403

805267596SurgicalInstrD9

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ORTHOKEY ITALIA SRL
UDI-DI code: 08052675960211
Reference / catalog number: 20902403

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View device family (Basic UDI)

Manufacturer information

Organization name: ORTHOKEY ITALIA SRL
SRN: IT-MF-000026488
Manufacturer status: Active

Related devices

4 in 1 Guide - Implantcast-5C805267596SurgicalInstrD9On the market GS.N0120805267596SurgicalInstrD9On the market GS.N0130805267596SurgicalInstrD9On the market GS.N0131805267596SurgicalInstrD9On the market Alignment Verification ROD805267596SurgicalInstC1LVOn the market

Certificates

Certificate health across this manufacturer's portfolio.

IT348354Issued
Quality management systemNotified body: 1370Expiry: Dec 16, 2030

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08052675960211
Basic UDI-DI: 805267596SurgicalInstrD9
Reference / catalog number: 20902403
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: Adjustable support to be fixed to bone that holds sensor and cutting blocks
Additional information URL: https://www.orthokey.com/
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)08052675960211

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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.

L0999ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER

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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