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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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Proteinase K (RTU) — 2 UDI-DI variants, IVDR (VITRO, S.A.)

MD Atlas
VITRO, S.A.

Data from EUDAMED, last updated May 23, 2026

Proteinase K (RTU)

8435421200591YE

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: VITRO, S.A.

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Device characteristics

Reagent

Identity & classification

Basic UDI-DI: 8435421200591YE
Device name: Proteinase K (RTU)
Device model: MAD-011892QEVS
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Sep 17, 2025

Manufacturer & authorised representative

Manufacturer

Name: VITRO, S.A.
SRN: ES-MF-000001498
Country: Spain
Email: regulatory@vitro.bio
Phone: +34 954 933 200

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01K5BCWQ309BG0XYFQZ5CBEA77

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

MAD-011892QEVS08435804520713
MAD-011892QEVSBC08435804522328