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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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I/A kit for Pulsar II MS: cassette,… — 2 UDI-DI variants, MDR

MD Atlas
Optikon 2000 S.p.A.

Data from EUDAMED, last updated May 30, 2026

I/A kit for Pulsar II MS: cassette, drainage bag

8059308SUR_TBS_008ZT

2 UDI-DI variants

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

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Optikon 2000 S.p.A.

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 8059308SUR_TBS_008ZT
Device name: I/A kit for Pulsar II MS: cassette, drainage bag
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Apr 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: Optikon 2000 S.p.A.
SRN: IT-MF-000017618
Country: Italy
Email: mronchetti@bvimedical.com
Phone: +39 06 8888410

Variants by status

UDI-DI variants

2 UDI-DI variants

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Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
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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
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Basic UDI-DI reagent

19170408059308010398
19170308059308008890