Identity
- Trade Name
- FX-V1 EUDAMED
- Device Name
- FX-V1 EUDAMED
- Model / Reference
- FX-V1 EUDAMEDREF-CHAM-FX1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800038900813 EUDAMED
- Basic UDI-DI
- 88000389FX-V1K4 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
Fx-V1 by Dong-A Chammed Co., Ltd. — Class I — 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 | 88000389FX-V1K4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dong-A Chammed Co., Ltd.
- EUDAMED SRN
- KR-MF-000021773
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED ccddb54f-20c0-4088-a6c0-963bc75751f0 61 fields · synced Jun 19, 2026