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Surgical Shadowless Lamps
EUDAMEDFDA UDIClass I (EU MDR)
Ref YDE700/500Model YDE700/500、YDE700/700、YDE500/500、YDE700、YDE500、YDE300、YDE200、YDE500D、YDE300D YDZ700/500、YDZ700/700、YDZ500/500、YDZ700、YDZ500、YDZ500D
Identity
- Trade Name
- Maisilide FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Surgical Shadowless Lamps EUDAMED
- Model / Reference
- YDE700/500、YDE700/700、YDE500/500、YDE700、YDE500、YDE300、YDE200、YDE500D、YDE300D YDZ700/500、YDZ700/700、YDZ500/500、YDZ700、YDZ500、YDZ500D EUDAMEDYDE700/500 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976696812200 EUDAMED06976696812408 FDA UDI
- Basic UDI-DI
- 697669681EHB001Q2 EUDAMED
- Direct Marketing DI
- 06976696812200 EUDAMED
- FDA Product Code
- FTD FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
Surgical Shadowless Lamps by Shandong Deman Medical Equipment Group Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697669681EHB001Q2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shandong Deman Medical Equipment Group Co., LTD
- EUDAMED SRN
- CN-MF-000037481
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED e64049fa-99f6-4bb3-bbd8-104046843e4a 61 fields · synced Jul 11, 2026
- FDA UDI c9ac6d0e-8fcf-4609-9da0-d1df5d48a0f5 32 fields · synced May 30, 2026