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Operating Lamp
EUDAMEDClass I (EU MDR)
Ref LED.DT61Model LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED
Identity
- Trade Name
- Operating Lamp EUDAMED
- Device Name
- Operating Lamp EUDAMED
- Model / Reference
- LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED EUDAMEDLED.DT61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452538 EUDAMED
- Basic UDI-DI
- 697722645BTOL01QP 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
Operating Lamp by Nanjing Poweam Medical 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 | 697722645BTOL01QP | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Poweam Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000040207
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b4e3e6fb-f346-4cc4-9749-c7a7d8f9e289 61 fields · synced Jun 18, 2026