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Operating Lamp
EUDAMEDClass I (EU MDR)
Ref LED.D78Model 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.IILEDRef 600-IIRef 05L.IRef 500-IIISRef 600/600-IIRef 500-IIIRef LED.MD61Ref LED.MSTZ5Ref EJ06Ref EJ02Ref LED.MSTZ4Ref 01L.IILEDRef LED700/700Ref LED.DT61/DT61Ref 05HRef EJ03Ref 700-IIIRef 01L.ILRef LED.DTR78/DTR78Ref 01L.IVLEDRef 01L.IIILEDRef EJ01Ref 700/500-IIIRef 09HRef 12HRef 05H.IIIRef LED500 Ref LED500/500Ref 04H.IRef 12LRef LED.DTR78Ref LED.STZ5/STZ5
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.D78 EUDAMED600-II EUDAMED05L.I EUDAMED500-IIIS EUDAMED600/600-II EUDAMED500-III EUDAMEDLED.MD61 EUDAMEDLED.MSTZ5 EUDAMEDEJ06 EUDAMEDEJ02 EUDAMEDLED.MSTZ4 EUDAMED01L.IILED EUDAMEDLED700/700 EUDAMEDLED.DT61/DT61 EUDAMED05H EUDAMEDEJ03 EUDAMED700-III EUDAMED01L.IL EUDAMEDLED.DTR78/DTR78 EUDAMED01L.IVLED EUDAMED01L.IIILED EUDAMEDEJ01 EUDAMED700/500-III EUDAMED09H EUDAMED12H EUDAMED05H.III EUDAMEDLED500 EUDAMEDLED500/500 EUDAMED04H.I EUDAMED12L EUDAMEDLED.DTR78 EUDAMEDLED.STZ5/STZ5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977226452507 EUDAMED06977226452743 EUDAMED06977226452828 EUDAMED06977226452736 EUDAMED06977226452767 EUDAMED06977226452729 EUDAMED06977226452637 EUDAMED06977226452606 EUDAMED06977226453016 EUDAMED06977226452972 EUDAMED06977226452613 EUDAMED06977226452651 EUDAMED06977226453030 EUDAMED06977226452521 EUDAMED06977226452880 EUDAMED06977226452989 EUDAMED06977226452712 EUDAMED06977226452941 EUDAMED06977226452491 EUDAMED06977226452675 EUDAMED06977226452668 EUDAMED06977226452965 EUDAMED06977226452705 EUDAMED06977226452873 EUDAMED06977226452866 EUDAMED06977226452897 EUDAMED06977226453061 EUDAMED06977226453054 EUDAMED06977226452927 EUDAMED06977226452781 EUDAMED06977226452484 EUDAMED06977226452552 EUDAMED
- Basic UDI-DI
- 697722645BTOL01QP EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDBelgium 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 Lamp by Nanjing Poweam Medical 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 | 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 (32)
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- EUDAMED df0cad85-60d1-4bc0-a2fb-0b71a2e26f17 61 fields · synced May 11, 2026
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- EUDAMED 3ac9c17d-5c2e-40b4-a973-1176fbc6a740 61 fields · synced May 17, 2026
- EUDAMED ca8956af-d239-417b-9bfb-90071eae8257 61 fields · synced May 17, 2026
- EUDAMED ebdad79b-aac3-486e-911b-d870cbed712d 61 fields · synced May 17, 2026
- EUDAMED 9b798d68-de2d-48ab-a916-889b172c6770 61 fields · synced May 17, 2026
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- EUDAMED 8d8c9541-0384-424f-96d3-0ee5d81af52e 61 fields · synced May 18, 2026
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- EUDAMED 1b239d02-1986-456a-8ac2-a89662d2fb99 61 fields · synced May 18, 2026
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- EUDAMED fc5b68f0-be69-4cd2-86af-23a0194455ab 61 fields · synced May 18, 2026
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