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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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Scoreflex PTA — 1 UDI-DI variant, MDD (OrbusNeich Medical, B.V.)

MD Atlas
OrbusNeich Medical, B.V.

Data from EUDAMED, last updated May 30, 2026

Scoreflex PTA

B-08717853298288

1 UDI-DI variant

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

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Manufacturer: OrbusNeich Medical, B.V.

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Device characteristics

No device characteristics flagged

Legacy certificates

Certificate number: CE 619995
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: BSI Group The Netherlands B.V. (2797)
Validity: Apr 21, 2023

Identity & classification

Basic UDI-DI: B-08717853298288
Device name: Scoreflex PTA
Device model: Ø 4.0 x 20 mm
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class IIa
Version date: Aug 15, 2022

Manufacturer & authorised representative

Manufacturer

Name: OrbusNeich Medical, B.V.
SRN: NL-MF-000010907
Country: Netherlands
Email: onra@orbusneich.com
Phone: +31 33 254 1150

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01GAGMY13YM84QJYFJWY0270MV

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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

Scoreflex PTA08717853298288