Anyview-240DR
by Ecotron Co., Ltd South Korea EUDAMEDGUDID
Ref ECO-ER-CAT-001CModel Anyview-240DR
Product code OXOEMDN Z11039017
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-08800019200253 | Date26 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08800019200253 | Date29 Mar 2018 | StatusIn distribution |
Coverage
- Expiring (legacy directive)
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Anyview-240DR EUDAMEDNa GUDID
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital
- Device Name
- C-Arm X-ray system
- Model / Ref / Catalog
- Anyview-240DR, ECO-ER-CAT-001C, ECO-ER-CAT-001DR
- Primary DI / UDI-DI
- 08800019200253
- Basic UDI-DI
- B-08800019200253
- 510(k) Number
- FDA Product Code
- OXO, JAA, OWB
- EMDN Code
- Z11039017 Mobile radioscopic units
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 892.1650
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Size
- Weight — 250 KilogramWidth — 800 MillimeterLength — 1852 MillimeterHeight — 1650 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- KR-MF-000016249
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Ecotron Co., Ltd
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
Sources (2)
- EUDAMED 6c6e8efc-456a-48c7-af1a-f43e7152c770
- FDA UDI 2b994469-d7aa-4454-886a-6c7928b92007