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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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ORTHOKEY Surgical instruments IR — 57 UDI-DI variants, MDR

MD Atlas
ORTHOKEY ITALIA SRL

Data from EUDAMED, last updated May 31, 2026

ORTHOKEY Surgical instruments IR

805267596SurgicalInstrD9

57 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: ORTHOKEY ITALIA SRL

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Device characteristics

Reusable

Legacy certificates

Certificate number: IT348354
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: BUREAU VERITAS ITALIA S.P.A. (1370)
Validity: Dec 17, 2025 → Dec 16, 2030

Identity & classification

Basic UDI-DI: 805267596SurgicalInstrD9
Device name: —
Device model: ORTHOKEY Surgical instruments IR
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Mar 24, 2026

Manufacturer & authorised representative

Manufacturer

Name: ORTHOKEY ITALIA SRL
SRN: IT-MF-000026488
Country: Italy
Email: quality.assurance@orthokey.eu

Variants by status

UDI-DI variants

57 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01KMFRBSGX3ESBN1VR2C5HBX5J

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Thickness verification Plan 24mm08052675960358
Thickness verification Plan 26mm08052675960365
2090322808052675960372
Tibial Spacer 0-13 mm08052675960075
GS.N104008052675960556
Verification Plan Perseus08052675960136
UK.N010008052675960778

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