Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ 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.

Organization name
UDI-DI code
Reference / catalog number

gigasept Instru AF — Class IIa MDR by Schülke & Mayr GmbH

MD Atlas
Schülke & Mayr GmbH

EUDAMED last updated this device on Apr 9, 2026

gigasept Instru AF

4032651BSC00000037AH

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Schülke & Mayr GmbH
UDI-DI code: 04032651074235
Reference / catalog number: 107423

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?

Manufacturer information

Organization name: Schülke & Mayr GmbH
SRN: DE-MF-000005701
Manufacturer status: Active

Related devices

Adapter for thermosept PAA4032651BSC000000109VOn the market 1139404032651BSC000000209YOn the market antifect N liquid4032651BSC000000209YOn the market antifect N liquid4032651BSC000000209YOn the market 700034004032651BSC00000018ADOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW076
EUDAMED did not publish a description for this code.
CW081
EUDAMED did not publish a description for this code.
CW102
EUDAMED did not publish a description for this code.
CW999
not suitable for final disinfection of semicritical and critical medical devices

Market distribution

Primary placement in Croatia; available across 3 countries total.

Country	On market since	Until
CroatiaPrimary placement		Still on market
Bulgaria		Still on market
Romania		Still on market

Device identification

Trade name: gigasept Instru AF
UDI-DI code: 04032651074235
Basic UDI-DI: 4032651BSC00000037AH
Reference / catalog number: 107423
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12011385CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification