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gigasept Instru AF
EUDAMEDClass IIa (EU MDR)
Ref 107413Ref 107425Ref 107428Ref 107423
Identity
- Trade Name
- gigasept Instru AF EUDAMED
- Device Name
- gigasept Instru AF EUDAMED
- Model / Reference
- 107413 EUDAMED107425 EUDAMED107428 EUDAMED107423 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651074136 EUDAMED04032651074259 EUDAMED04032651074280 EUDAMED04032651074235 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
- Germany EUDAMEDCroatia EUDAMEDPoland 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 (4)
- EUDAMED 47aa76e7-73a1-46e7-a484-545eb89f4836 61 fields · synced Oct 6, 2026
- EUDAMED 136c15c7-b7e1-48b4-9507-2025470fad59 61 fields · synced May 17, 2026
- EUDAMED 04aa218c-17cf-4b19-bf42-5bc41793e2fc 61 fields · synced May 19, 2026
- EUDAMED e2a9c150-2109-4a4c-9f4c-7ed55a426c5b 61 fields · synced May 19, 2026