Identity
- Trade Name
- gigasept Instru AF EUDAMED
- Device Name
- gigasept Instru AF EUDAMED
- Model / Reference
- 107426 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651074266 EUDAMED
- Basic UDI-DI
- 4032651BSC00000037AH EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
gigasept Instru AF by Schülke & Mayr GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4032651BSC00000037AH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (1)
- EUDAMED b48cb7d9-1f6b-4755-8b1d-ccedfdd13822 61 fields · synced Jun 19, 2026