Identity
- Trade Name
- gigasept powerSET3 rinsing wipe EUDAMED
- Device Name
- gigasept powerSET3 rinsing wipe EUDAMED
- Model / Reference
- 70003674 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651985548 EUDAMED
- Basic UDI-DI
- 4032651BSC00000065AN EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 powerSET3 rinsing wipe by Schülke & Mayr GmbH — Class I — 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 | 4032651BSC00000065AN | Class I | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (1)
- EUDAMED 16c8982c-1366-4fd1-a9e4-4245318e2075 61 fields · synced Oct 6, 2026