Identity
- Trade Name
- Meissa OT Ultra EUDAMED
- Device Name
- Luna EMG EUDAMED
- Model / Reference
- Luna EMG EUDAMEDMeissa OT Ultra EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903228161049 EUDAMED
- Basic UDI-DI
- 590322RehabRobot9F EUDAMED
- Direct Marketing DI
- 05903228161049 EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Rubber dam, Hevea-latex
Meissa OT Ultra by Egzotech Spółka Z Ograniczoną Odpowiedzialnością — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rubber dam, Hevea-latex.
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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 | 590322RehabRobot9F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Egzotech Spółka Z Ograniczoną Odpowiedzialnością
- EUDAMED SRN
- PL-MF-000003826
Sources (1)
- EUDAMED 7f8d9de0-d8f5-49fa-ad91-9082ec42d9af 61 fields · synced Oct 5, 2026