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Operation Light
EUDAMEDClass I (EU MDR)
Ref AKL-LED·D78/D78Model AKL-K700/500，AKL-G700/500，AKL-LED·D78/D78 ，AKL700/500-III，AKL-LED·MSZ4Ref AKL-LED·MSZ4Ref AKL-K700/500Ref AKL700/500-IIIRef AKL-G700/500
Identity
- Device Name
- Operation Light EUDAMED
- Model / Reference
- AKL-K700/500，AKL-G700/500，AKL-LED·D78/D78 ，AKL700/500-III，AKL-LED·MSZ4 EUDAMEDAKL-LED·D78/D78 EUDAMEDAKL-LED·MSZ4 EUDAMEDAKL-K700/500 EUDAMEDAKL700/500-III EUDAMEDAKL-G700/500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976062314031 EUDAMED06976062314055 EUDAMED06976062314017 EUDAMED06976062314048 EUDAMED06976062314024 EUDAMED
- Basic UDI-DI
- 697606231004J6 EUDAMED
- EMDN Code
- Z12010799 SCIALYTIC LAMP LIGHTING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Operation Light by Jiangsu Rooe Medical Technology 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 | 697606231004J6 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Rooe Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000033285
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (5)
- EUDAMED 2d2c7401-5ba9-4b92-b895-a74cfcfa0d34 61 fields · synced Aug 4, 2026
- EUDAMED 0cc7e75c-7588-46c3-b4f2-b6aaab6fee0f 61 fields · synced May 17, 2026
- EUDAMED 8404fbb9-de3d-412b-8fe8-367d7cc7691c 61 fields · synced May 17, 2026
- EUDAMED 424c052f-74c5-4ed3-9d8c-5ae9b50dbeb6 61 fields · synced May 18, 2026
- EUDAMED 0e7bb6fa-cf08-4ff9-ae63-98fd13159842 61 fields · synced May 18, 2026