Identity
- Trade Name
- rotasept EUDAMED
- Device Name
- rotasept EUDAMED
- Model / Reference
- 104741 EUDAMED104744 EUDAMED104743 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651047413 EUDAMED04032651047444 EUDAMED04032651047437 EUDAMED
- Basic UDI-DI
- 4032651BSC00000029AJ EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDCroatia 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
rotasept 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 | 4032651BSC00000029AJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (3)
- EUDAMED dba6a8b6-0623-4b63-b95e-6b01f9c1d15c 61 fields · synced Oct 6, 2026
- EUDAMED 142ca89a-0cd7-4717-b2be-e34cf6ab7358 61 fields · synced May 18, 2026
- EUDAMED f1293473-2367-4a71-a77d-0654c274e114 61 fields · synced May 18, 2026