Identity
- Trade Name
- V1 SMART EUDAMED
- Model / Reference
- V1 SMART EUDAMEDREF-CHAM-V1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800038900189 EUDAMED
- Basic UDI-DI
- 880001000142 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
V1 Smart 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 | 880001000142 | Class I | Active |
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Manufacturer
- Manufacturer
- Dong-A Chammed Co., Ltd.
- EUDAMED SRN
- KR-MF-000021773
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 26846d2a-e399-46a5-b1e4-c4ed19d92c4a 61 fields · synced Jun 19, 2026