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operation lamp
EUDAMEDClass I (EU MDR)
Ref N/AModel FL700/700,+C2:C37 FL700/500, FL500/500, FL700/ FL500, FZ700/700, FZ700/500, FZ500/500, FZ700 FZ500, FL720/720, FL720/520, FL520/520, FL520 FL720, FLSX6+6FLK5+3, FLK5, FLk3, FLXYC3/3 FLXYC3, FKWY-L4, FKWY-H4, FKWY-L5, FKWY-H5 FLM1700, etc
Identity
- Device Name
- operation lamp EUDAMED
- Model / Reference
- FL700/700,+C2:C37 FL700/500, FL500/500, FL700/ FL500, FZ700/700, FZ700/500, FZ500/500, FZ700 FZ500, FL720/720, FL720/520, FL520/520, FL520 FL720, FLSX6+6FLK5+3, FLK5, FLk3, FLXYC3/3 FLXYC3, FKWY-L4, FKWY-H4, FKWY-L5, FKWY-H5 FLM1700, etc EUDAMEDN/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973424802014 EUDAMED
- Basic UDI-DI
- 697342480L005EC 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
operation lamp by Shanghai Flower Medical Equipment CO., LTD — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697342480L005EC | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Flower Medical Equipment CO., LTD
- EUDAMED SRN
- CN-MF-000033151
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 549608e4-458d-46a9-a8ff-32e69350f442 61 fields · synced Jul 19, 2026
- EUDAMED 549608e4-458d-46a9-a8ff-32e69350f442-1 61 fields · synced Jun 10, 2026