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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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NuEra Tight 1ch — 2 UDI-DI variants, MDR (BIOS Srl)

MD Atlas
BIOS Srl

Data from EUDAMED, last updated May 31, 2026

NuEra Tight 1ch

805204950SKRFD4

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Manufacturer: BIOS Srl

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Device characteristics

Active device

Identity & classification

Basic UDI-DI: 805204950SKRFD4
Device name: —
Device model: NuEra Tight 1ch
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIb
Version date: Sep 23, 2025

Manufacturer & authorised representative

Manufacturer

Name: BIOS Srl
SRN: IT-MF-000022514
Country: Italy
Email: quality@biosgroup.eu
Phone: +39 0227304275

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01K5VGMK8KW50SDK7DAT3A6DZ6

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

NuEra Tight08052049500302
OptiPLUS08052049500371