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Operating Light
EUDAMEDClass I (EU MDR)
Ref PROLEDD620/620Model LEDD700/700,LEDD700,LEDD620/620,LEDD620,LEDD500/500,LEDD500,LEDD700/500,LEDD730/730,LEDD730,LEDD740/740,LEDD740,LEDD730/740,LEDD260/260,LEDD260,LEDD200/200, LEDD200,LEDB700,LEDB620,LEDB500,LEDB730,LEDB740,etcRef LEDB730Ref PROLEDL700Ref PROLED H4DRef LEDD700/700Ref LEDL740Ref LEDL100Ref PROLEDD740/740Ref PROLED H4SRef LEDD700Ref LEDD740Ref PROLED H7DRef LEDD730/730Ref LEDL260Ref LEDD740/740Ref LEDD730Ref LEDD260/260Ref LEDD730/740Ref LEDD700/500Ref PROLED H8SRef PROLED H5SRef LEDL620Ref PROLEDB700Ref PROLEDB620Ref PROLEDD620Ref PROLEDD500/500
Identity
- Device Name
- Operating Light EUDAMED
- Model / Reference
- LEDD700/700,LEDD700,LEDD620/620,LEDD620,LEDD500/500,LEDD500,LEDD700/500,LEDD730/730,LEDD730,LEDD740/740,LEDD740,LEDD730/740,LEDD260/260,LEDD260,LEDD200/200, LEDD200,LEDB700,LEDB620,LEDB500,LEDB730,LEDB740,etc EUDAMEDPROLEDD620/620 EUDAMEDLEDB730 EUDAMEDPROLEDL700 EUDAMEDPROLED H4D EUDAMEDLEDD700/700 EUDAMEDLEDL740 EUDAMEDLEDL100 EUDAMEDPROLEDD740/740 EUDAMEDPROLED H4S EUDAMEDLEDD700 EUDAMEDLEDD740 EUDAMEDPROLED H7D EUDAMEDLEDD730/730 EUDAMEDLEDL260 EUDAMEDLEDD740/740 EUDAMEDLEDD730 EUDAMEDLEDD260/260 EUDAMEDLEDD730/740 EUDAMEDLEDD700/500 EUDAMEDPROLED H8S EUDAMEDPROLED H5S EUDAMEDLEDL620 EUDAMEDPROLEDB700 EUDAMEDPROLEDB620 EUDAMEDPROLEDD620 EUDAMEDPROLEDD500/500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974423970497 EUDAMED16974423970268 EUDAMED16974423970626 EUDAMED16974423970459 EUDAMED16974423970145 EUDAMED16974423970305 EUDAMED16974423970756 EUDAMED16974423970558 EUDAMED16974423970442 EUDAMED16974423970084 EUDAMED16974423970220 EUDAMED16974423970350 EUDAMED16974423970190 EUDAMED16974423970725 EUDAMED16974423970213 EUDAMED16974423970206 EUDAMED16974423970671 EUDAMED16974423970237 EUDAMED16974423970107 EUDAMED16974423970312 EUDAMED16974423970404 EUDAMED16974423970114 EUDAMED16974423970589 EUDAMED16974423970596 EUDAMED16974423970503 EUDAMED16974423970510 EUDAMED
- Basic UDI-DI
- 697442397Light001LQ 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 Hefei Health Science And Technology Development 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 | 697442397Light001LQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011677
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (26)
- EUDAMED 9738b999-7725-4048-ac70-3a64b51f12df 61 fields · synced Aug 4, 2026
- EUDAMED d43b83fb-dc23-425d-b924-ff98dec3608c 61 fields · synced May 16, 2026
- EUDAMED d814eee2-1bf6-4303-902f-b96e3406b77a 61 fields · synced May 17, 2026
- EUDAMED 5d05081c-34b6-465c-bb45-7c37d8e0d322 61 fields · synced May 17, 2026
- EUDAMED 9642fa77-2168-496f-850d-bc54d395c4e8 61 fields · synced May 17, 2026
- EUDAMED 09cf0958-38a9-40d1-b456-d574b6040ee9 61 fields · synced May 17, 2026
- EUDAMED 92032cf4-85a5-4f50-b19e-9bd4d6e0d3bf 61 fields · synced May 17, 2026
- EUDAMED 997aba65-7d3c-4d8d-a1e4-8eec1a5b0286 61 fields · synced May 17, 2026
- EUDAMED ae0e51bf-3326-4f9c-a022-5067358fc85a 61 fields · synced May 17, 2026
- EUDAMED 24aebd60-7495-4fdb-994e-7631ae004549 61 fields · synced May 18, 2026
- EUDAMED 6899d8b9-4598-4965-bc5f-d29c6b0fa143 61 fields · synced May 18, 2026
- EUDAMED c615561c-e7e1-4e85-abf7-5c7e8980f1e5 61 fields · synced May 18, 2026
- EUDAMED 1614d098-b53c-48cc-9540-e0a388ce14e3 61 fields · synced May 18, 2026
- EUDAMED 6e62dd57-1724-4f0d-8f85-707fc033dec2 61 fields · synced May 18, 2026
- EUDAMED 92932089-649e-4259-a608-6a35261e6601 61 fields · synced May 18, 2026
- EUDAMED 713f25f4-7a54-4442-b5c0-b8b087604124 61 fields · synced May 18, 2026
- EUDAMED 3e9bbb0b-f281-4c63-b921-168d9a0d0e07 61 fields · synced May 18, 2026
- EUDAMED 0189b458-8060-46f8-8e49-f09a84815bfb 61 fields · synced May 18, 2026
- EUDAMED bbf1e47a-0ffe-41f0-85db-8a7bb6567c01 61 fields · synced May 18, 2026
- EUDAMED 7d78136d-5dec-454d-a99f-bd4d2ab03413 61 fields · synced May 18, 2026
- EUDAMED a2c2a928-84e8-4ccf-81ac-85d26cde0f04 61 fields · synced May 18, 2026
- EUDAMED a8fcac98-940c-44aa-abd7-b12f14e57737 61 fields · synced May 18, 2026
- EUDAMED da5acb43-3430-4a53-8f0f-2bd932dabe3c 61 fields · synced May 18, 2026
- EUDAMED 31d684bf-3a70-4bed-94a0-f50b91e8c92f 61 fields · synced May 18, 2026
- EUDAMED 350170c9-08d8-430f-89f5-043c101ec1ec 61 fields · synced May 19, 2026
- EUDAMED 7abfb8bd-2fc2-4d2c-a4e6-3d8489c1020d 61 fields · synced May 19, 2026