Identity
- Trade Name
- AVIEW Brain EUDAMED
- Device Name
- AVIEW EUDAMED
- Model / Reference
- CLS-USR-002(EU) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800025300183 EUDAMED
- Basic UDI-DI
- 88000253A001B2 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
AVIEW Brain by Coreline Soft Co., Ltd. — Class IIb — 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 | 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 (1)
- EUDAMED 48ef432b-6297-4b2f-93c1-39f0911a10dc 61 fields · synced Jun 18, 2026