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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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SINGLE-USE GUIDING INSTRUMENTS — 2 UDI-DI variants, MDR

MD Atlas
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L

Data from EUDAMED, last updated May 23, 2026

SINGLE-USE GUIDING INSTRUMENTS

84353898SINGLE-GUIDEFG

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 84353898SINGLE-GUIDEFG
Device name: SINGLE-USE GUIDING INSTRUMENTS
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Jul 2, 2025

Manufacturer & authorised representative

Manufacturer

Name: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L
SRN: ES-MF-000001701
Country: Spain
Email: technicalmanager@bti-implant.es

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01JZ4YYRXE2KR2YN9YQNQ1SKFR

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

S3CG08435389828174
SCG08435389827559