Identity
- Trade Name
- ECOVIEW 9PLUS EUDAMED
- Device Name
- ECOVIEW 9PLUS EUDAMED
- Model / Reference
- ECOVIEW 9PLUS EUDAMEDEBF-EV9-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800123000022 EUDAMED
- Basic UDI-DI
- B-08800123000022 EUDAMED
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, analogue
Ecoview 9plus by ECORAY Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800123000022 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ECORAY Co., Ltd
- EUDAMED SRN
- KR-MF-000029286
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 673ec1c3-2bfc-4ebd-8158-8d2036d292d3 61 fields · synced Jul 30, 2026