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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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Paclitaxel coated balloon catheter… — 1 UDI-DI variant, MDD

MD Atlas
AR Baltic Medical UAB

Data from EUDAMED, last updated May 30, 2026

Paclitaxel coated balloon catheter ELUTAX "3"

B-04772085003974

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: AR Baltic Medical UAB

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Device characteristics

Administers medicineIncorporates a medicinal product

Legacy certificates

Certificate number: M.2018.106.9148
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)
Validity: May 27, 2024

Certificate number: M.2018.106.9148-1
Type: refdata.legacy.mdd-certificate-type.ii-4
Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)
Validity: May 27, 2024

Identity & classification

Basic UDI-DI: B-04772085003974
Device name: Paclitaxel coated balloon catheter ELUTAX "3"
Device model: N-ELUTAX “3” 15350
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: May 27, 2026

Manufacturer & authorised representative

Manufacturer

Name: AR Baltic Medical UAB
SRN: LT-MF-000004402
Country: Lithuania
Email: info@arbalticmedical.com
Phone: +37052034473

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KSMSHYRVKN37AHQ1JYNAT6QJ

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

N-ELUTAX “3”04772085003974