← Back to catalogue
EinsteinVision®
EUDAMEDClass IIa (EU MDR)
Ref EV2-000055Model Sterile Endoscopic Sheaths for Rigid Endoscopes
Identity
- Trade Name
- EinsteinVision® EUDAMED
- Model / Reference
- Sterile Endoscopic Sheaths for Rigid Endoscopes EUDAMEDEV2-000055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250480105429 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schölly Fiberoptic Gmbh
- EUDAMED SRN
- DE-MF-000005618
Sources (1)
- EUDAMED 4694e9bd-c0db-404a-b413-c0744b1cb260 61 fields · synced Jul 28, 2026