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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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VARIANT, Modular lower extremity… — 1 UDI-DI variant, MDR

MD Atlas
ProSpon, spol. s r.o.

Data from EUDAMED, last updated May 30, 2026

VARIANT, Modular lower extremity replacement

8592395VARIANTLE64

1 UDI-DI variant

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: ProSpon, spol. s r.o.

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Device characteristics

Implantable

Legacy certificates

Certificate number: 2026-MDR/QS-003
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: 3EC International a.s. (2265)
Validity: Jan 5, 2026 → Apr 26, 2029

Certificate number: 2026-MDR/TD-003
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: 3EC International a.s. (2265)
Validity: Jan 5, 2026 → Apr 26, 2029

Identity & classification

Basic UDI-DI: 8592395VARIANTLE64
Device name: VARIANT, Modular lower extremity replacement
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: ProSpon, spol. s r.o.
SRN: CZ-MF-000019992
Country: Czechia
Email: prospon@prospon.cz
Phone: +420312247763

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KSHQ3FWD6D42XP619ZCXADDX

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

VARIANT, CoCrMo Head (∢12/14) 28 S08595565120321