Pricing Sign in

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

gigazyme — 2 UDI-DI variants, MDR (Schülke & Mayr GmbH)

MD Atlas
Schülke & Mayr GmbH

Data from EUDAMED, last updated May 23, 2026

gigazyme

4032651BSC00000056AM

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: Schülke & Mayr GmbH

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 4032651BSC00000056AM
Device name: gigazyme
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Feb 12, 2026

Manufacturer & authorised representative

Manufacturer

Name: Schülke & Mayr GmbH
SRN: DE-MF-000005701
Country: Germany
Email: info@schuelke.com

Variants by status

UDI-DI variants

2 UDI-DI variants

Sign in to export

Exports are reserved for signed-in users. Sign in or create an account to continue.

Email

Password

No account yet?

Export results

Applied filters

basicUdiUlid01KH8W1C88YNK3GV80N3JJ5C20

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

7000340804032651984275
7000340904032651984282