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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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GENUS UNI TIBIAL INSERT SIZE 2 H10 LM/RL — 1 UDI-DI variant, MDD

MD Atlas
Adler Ortho S.p.A

Data from EUDAMED, last updated May 30, 2026

GENUS UNI TIBIAL INSERT SIZE 2 H10 LM/RL

B-08057714811165

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class III

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: Adler Ortho S.p.A

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Device characteristics

Implantable

Legacy certificates

Certificate number: 233-01-03-DM
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: ITALCERT SRL (0426)
Validity: Nov 6, 2023

Identity & classification

Basic UDI-DI: B-08057714811165
Device name: —
Device model: GENUS UNI TIBIAL INSERT SIZE 2 H10 LM/RL
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: May 19, 2026

Manufacturer & authorised representative

Manufacturer

Name: Adler Ortho S.p.A
SRN: IT-MF-000010164
Country: Italy
Email: info@adlerortho.com
Phone: +39 026154371

Variants by status

UDI-DI variants

1 UDI-DI variant

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Applied filters

basicUdiUlid01KS01TPH5YH1Y1G333TYAQ0HF

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

GENUS UNI08057714811165