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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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BT 4500S S/I — 8 UDI-DI variants, IVDR (Biotecnica Instruments S.r.l.)

MD Atlas
Biotecnica Instruments S.r.l.

Data from EUDAMED, last updated May 30, 2026

BT 4500S S/I

0803362296444U8

8 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: Biotecnica Instruments S.r.l.

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 0803362296444U8
Device name: BT 4500S S/I
Device model: BT 4500S S/ISE
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: May 17, 2022

Manufacturer & authorised representative

Manufacturer

Name: Biotecnica Instruments S.r.l.
SRN: IT-MF-000008115
Country: Italy
Email: giannini@biotecnica.it

Variants by status

UDI-DI variants

8 UDI-DI variants

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Export results

Applied filters

basicUdiUlid01G38PXRNHF5Y1976Q2YN6758W

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

BT4500S S/I-C08033622964476
BT4500S S/I-B08033622964513
BT4500S S/I-G08033622964773
BT4500S S/I-D08033622964520
BT4500S S/I-F08033622964537
BT4500S S/I-E08033622964469
BT 4500S S/I08033622964445
BT4500S S/I-A08033622964506