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Lumicare
EUDAMEDClass IIb (EU MDR)
Ref TEE001Model TEERef ONE Lite001-D750-0101 Ref ONE-D750-0101
Identity
- Trade Name
- Lumicare EUDAMED
- Device Name
- Disinfection System for Ultrasound Probe EUDAMEDUVC Disinfection System for Ultrasound Probe EUDAMED
- Model / Reference
- TEE EUDAMEDTEE001 EUDAMEDONE Lite001-D750-0101 EUDAMEDONE-D750-0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973833410053 EUDAMED06973833410039 EUDAMED06973833410008 EUDAMED
- Basic UDI-DI
- 697383341TEE001J9 EUDAMED6973833410008AA EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Lumicare by Lumicare Medtech 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 | 697383341TEE001J9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Lumicare Medtech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023958
- Authorised Representative
- NEO HEALTHIES LIMITED IE-AR-000000905
Sources (3)
- EUDAMED b78ee155-35dc-4190-9d87-4a27d31a4d53 61 fields · synced Jul 9, 2026
- EUDAMED 5bb93b44-fa9b-4866-857c-b78bbf2a4984 61 fields · synced May 18, 2026
- EUDAMED b97ffa08-9489-4af2-a50b-4cdfc23ec3e7 61 fields · synced May 18, 2026