Identity
- Trade Name
- gigasept powerSET3 EUDAMEDgigasept powerSET3 disinfection wipe EUDAMED
- Device Name
- gigasept powerSET3 EUDAMEDgigasept powerSET3 disinfection wipe EUDAMED
- Model / Reference
- 70003677 EUDAMED70003676 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651985609 EUDAMED04032651985586 EUDAMED
- Basic UDI-DI
- 4032651BSC00000013A3 EUDAMED4032651BSC00000014A5 EUDAMED
- EMDN Code
- D050103 PERACETIC ACID FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- Reprocessing of non-lumed medical devices 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 by Schülke & Mayr GmbH — Class IIb — 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 | 4032651BSC00000013A3 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-PR-000039117
Sources (2)
- EUDAMED d76c3494-6419-45ed-ab01-efc29e1c4587 61 fields · synced Oct 6, 2026
- EUDAMED 510d9aca-b492-48a3-bab4-f84d0dbf9c38 61 fields · synced May 18, 2026