Identity
- Trade Name
- thermosept ED EUDAMED
- Device Name
- thermosept ED EUDAMED
- Model / Reference
- 181003 EUDAMED181007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651959457 EUDAMED04032651810079 EUDAMED
- Basic UDI-DI
- 4032651BSC00000042AA EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb 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
thermosept ED 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 | 4032651BSC00000042AA | Class IIb | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED 98f11cd0-7d4f-4bd2-9d58-3e36cc9eeee0 61 fields · synced Oct 6, 2026
- EUDAMED 2d84a60d-6c39-488d-bd22-f48915d80312 61 fields · synced May 19, 2026