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ELVeS® smart, Pullback device
EUDAMEDClass I (EU MDR)
Ref L-ElvesSmartModel ELVeS® smart
Identity
- Device Name
- ELVeS® smart, Pullback device EUDAMED
- Model / Reference
- ELVeS® smart EUDAMEDL-ElvesSmart EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049059300743 EUDAMED
- Basic UDI-DI
- 404905916ND EUDAMED
- EMDN Code
- Z12011080 LASER SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
ELVeS® smart, Pullback device by CeramOptec GmbH — Class I — 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 | 404905916ND | Class I | Active |
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Manufacturer
- Manufacturer
- CeramOptec GmbH
- EUDAMED SRN
- DE-MF-000005607
Sources (1)
- EUDAMED e2d680e1-7c30-4238-a564-ab640ffe07b2 61 fields · synced Jun 17, 2026