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Easywell
EUDAMEDClass I (EU MDR)
Ref EM32-4KAModel FHD01,EM32-4KA,UPS01,ETC-10,ETC-5,DVR-1
Identity
- Trade Name
- EASYWELL EUDAMED
- Device Name
- Shadowless Operation Light EUDAMED
- Model / Reference
- FHD01,EM32-4KA,UPS01,ETC-10,ETC-5,DVR-1 EUDAMEDEM32-4KA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471532145 EUDAMED
- Basic UDI-DI
- 697447153OL-ACCKY EUDAMED
- Direct Marketing DI
- 06974471532145 EUDAMED
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Easywell by Shantou Easywell Electronic Technologies 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 | 697447153OL-ACCKY | Class I | Active |
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Manufacturer
- Manufacturer
- Shantou Easywell Electronic Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000016725
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e67f3913-410c-43a9-8178-6b125abee216 61 fields · synced Jun 18, 2026