← Back to catalogue
Operating Light
EUDAMEDClass I (EU MDR)
Ref JHLED-M5L-2Model JHLED-M5、JHLED-M5-1、JHLED-M6、JHLED-M6-1、JHLED-M7、JHLED-M7-1、JHLED-M5L、JHLED-M5L-1、JHLED-M5L-2、JHLED-M6L-1、JHLED-M7/7、JHLED-M7/7-1、JHLED-M7/5、JHLED-M7/5-1、JHLED-M5/5、JHLED-M5/5-1、JHLED-M6/6、JHLED-M6-1/6-1、etc
Identity
- Device Name
- Operating Light EUDAMED
- Model / Reference
- JHLED-M5、JHLED-M5-1、JHLED-M6、JHLED-M6-1、JHLED-M7、JHLED-M7-1、JHLED-M5L、JHLED-M5L-1、JHLED-M5L-2、JHLED-M6L-1、JHLED-M7/7、JHLED-M7/7-1、JHLED-M7/5、JHLED-M7/5-1、JHLED-M5/5、JHLED-M5/5-1、JHLED-M6/6、JHLED-M6-1/6-1、etc EUDAMEDJHLED-M5L-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955569033263 EUDAMED
- Basic UDI-DI
- 69555690OL001SS EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Category: Operating room light system
Operating Light by Nantong Medical Apparatus Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- PWDII70DF CL K3 SATX13 — MAQUET SAS · Class I
- PWDII70SF SAT AIM CL K4 12 — MAQUET SAS · Class I
- PWDII50SF AIM MHS021 K4 1116 — MAQUET SAS · Class I
- PWDII55DF CL K4 SAX0810 — MAQUET SAS · Class I
- SLS 9000 — Avante · Class II
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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 | 69555690OL001SS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nantong Medical Apparatus Co., Ltd
- EUDAMED SRN
- CN-MF-000041916
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED df18929e-2dab-4597-bec3-6a49501b29f0 61 fields · synced Jun 19, 2026