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EinsteinVision®
EUDAMEDClass IIa (EU MDR)
Ref EV2-000056Model Sterile Endoscopic Sheaths for Rigid Endoscopes
Identity
- Trade Name
- EinsteinVision® EUDAMED
- Model / Reference
- Sterile Endoscopic Sheaths for Rigid Endoscopes EUDAMEDEV2-000056 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480105436 EUDAMED
- Basic UDI-DI
- 42504801STERILESHEATHSCQ EUDAMED
- EMDN Code
- Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
EinsteinVision® by SCHÖLLY FIBEROPTIC 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 | 42504801STERILESHEATHSCQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED e7b6bb1a-5a6a-45d1-8491-2a78fff18069 61 fields · synced Jun 20, 2026