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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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SP-Buffer — 2 UDI-DI variants, IVDR (Sysmex Europe SE)

MD Atlas
Sysmex Europe SE

Data from EUDAMED, last updated May 23, 2026

SP-Buffer

426015434SP-BufferNM

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: Sysmex Europe SE

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 426015434SP-BufferNM
Device name: SP-Buffer
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Jul 31, 2023

Manufacturer & authorised representative

Manufacturer

Name: Sysmex Europe SE
SRN: DE-MF-000022332
Country: Germany
Email: eudamedsupport@sysmex-europe.com

Variants by status

UDI-DI variants

2 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01H6N9TC55YE9Z7BSS1CMRGSD1

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

SP-Buffer pH 7.004260154340445
370-0030-404260154340247