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gigasept AF forte
EUDAMEDClass IIa (EU MDR)
Ref 70003413Ref 70003572Ref 70003412Ref 70003573
Identity
- Trade Name
- gigasept AF forte EUDAMED
- Device Name
- gigasept AF forte EUDAMED
- Model / Reference
- 70003413 EUDAMED70003572 EUDAMED70003412 EUDAMED70003573 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651984350 EUDAMED04032651984787 EUDAMED04032651984336 EUDAMED04032651984794 EUDAMED
- Basic UDI-DI
- 4032651BSC00000035AD EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDCzechia 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 AF forte 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 | 4032651BSC00000035AD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (4)
- EUDAMED abe8ad33-4ea6-481a-b125-a1f41882524a 61 fields · synced Oct 6, 2026
- EUDAMED cf2f4596-c871-432a-8ff6-41f3c27a6789 61 fields · synced May 17, 2026
- EUDAMED 739bc32f-3cb6-4f8c-8a7e-0ba68358c7a6 61 fields · synced May 18, 2026
- EUDAMED e35d4126-ebb1-467e-990d-275724409586 61 fields · synced May 19, 2026