AVIEW
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- AVIEW EUDAMED
- Device Name
- AVIEW EUDAMED
- Model / Reference
- CLS-USR-003(EU) EUDAMEDCLS-2021-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800025300114 EUDAMED
- Basic UDI-DI
- 88000253A001B2 EUDAMEDB-08800025300114 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDZ110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Special Device Type
- Software EUDAMED-1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
AVIEW is a Class IIb medical imaging device designed for diagnostic use in radiology. The device is manufactured by Coreline Soft Co., Ltd. and is not sterile, implantable, or reusable.
The AVIEW device is supplied as a standard medical device and is not intended for administering medicine or containing animal or human tissues. It is authorized under FDA 510K, MDD, and MDR regulations, with a reference number of CLS-USR-003(EU). The device is active and has a basic UDI of 88000253A001B2.
Frequently asked questions
What is the regulatory status of the AVIEW device?
The AVIEW device has received FDA 510K clearance and is also authorized under MDD and MDR regulations. It is classified as a Class IIb medical device, indicating a moderate risk level that requires special controls for safety and effectiveness.
Is the AVIEW device reusable or sterile?
No, the AVIEW device is not reusable and is not supplied in a sterile condition. It is designed for single-use applications and does not require sterilization before use, as indicated by the specifications.
What is the intended use of the AVIEW device?
The AVIEW device is classified as a medical imaging device intended for use in radiology. It is not designed for administering medicinal products or containing animal or human tissues, as specified in its device criteria.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171199 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K214036 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K200714 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K243689 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 88000253A001B2 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88000253A001B2 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Coreline Soft Co., Ltd.
- EUDAMED SRN
- KR-MF-000011555
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (3)
- EUDAMED a3a14747-a02e-4f63-8c57-d02aa86b404f 85 fields · synced Sep 18, 2026
- EUDAMED d0dafcfb-98e4-4bca-9636-864f130e985b 61 fields · synced May 18, 2026
- FDA 510(k) K171199 1 fields · synced May 18, 2026