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S300 Series
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref D-C-LVST-V3-202602-ENGModel ST500, ST500E, ST300, ST300ERef D-C-LVSL-V5-202602-ENGModel M310, M300Model C600, C700Model S200Model L400, M400Model E100Model L200, M210, M200Ref D-C-LVSM-V4-202510-ENGModel S250Model S300Model C500
Identity
- Trade Name
- LUVIS EUDAMEDS300 Series FDA UDILUVIS-C600 Series FDA UDILUVIS-C700 Series FDA UDIST500 Series FDA UDIS250 Series(Ceiling, Mobile FDA UDIS250 Series(Ceiling, Mobile) FDA UDI
- Generic Name
- Operating room light system FDA UDILED dental light, line-powered FDA UDIElectromechanical operating table base FDA UDI
- Device Name
- Operating Table EUDAMEDSurgical Luminaire EUDAMEDDental Light EUDAMEDLuminaire for diagnosis EUDAMEDAC 100-240V, 50/60Hz, 77-120VA FDA UDIAC 12-24 V, 50/60 Hz, 20-21 VA FDA UDIAC 100-240V, 50/60Hz, 61-84 VA(Non Camera) FDA UDIAC 100-240 V, 50-60 Hz, 30-45 VA FDA UDIAC 100-240V, 50/60Hz, 61-84VA(Non Camera) FDA UDIAC 100-240V, 50/60Hz, 500VA FDA UDIAC 100-240V, 50/60Hz, 77-120VA(Camera) FDA UDIAC 100-240 V, 50/60 Hz, 61-94VA FDA UDIAC 100-240V, 50/60HZ, 61-94VA FDA UDI
- Model / Reference
- ST500, ST500E, ST300, ST300E EUDAMEDD-C-LVST-V3-202602-ENG EUDAMEDM310, M300 EUDAMEDD-C-LVSL-V5-202602-ENG EUDAMEDC600, C700 EUDAMEDS200 EUDAMEDL400, M400 EUDAMEDE100 EUDAMEDL200, M210, M200 EUDAMEDS250 EUDAMEDD-C-LVSM-V4-202510-ENG EUDAMEDS300 EUDAMEDC500 EUDAMEDS300-23100 FDA UDIC600-H0S0A0 FDA UDIS300-20000 FDA UDIC700-E0S0A0 FDA UDIC600-C0S0A1 FDA UDIS300-24000 FDA UDIST500E FDA UDIC600-C0S0A0 FDA UDIS300-21000 FDA UDIS300-24100 FDA UDIC600-W0S0A1 FDA UDIC600-E0S0A1 FDA UDIS250-20000 FDA UDIS300-22000 FDA UDIST500 FDA UDIS250-22000 FDA UDIS300-25000 FDA UDI
- Description
- AC 100-240V, 50/60Hz, 77-120VA FDA UDIAC 12-24 V, 50/60 Hz, 20-21 VA FDA UDIAC 100-240V, 50/60Hz, 61-84 VA(Non Camera) FDA UDIAC 100-240 V, 50-60 Hz, 30-45 VA FDA UDIAC 100-240V, 50/60Hz, 61-84VA(Non Camera) FDA UDIAC 100-240V, 50/60Hz, 500VA FDA UDIAC 100-240V, 50/60Hz, 77-120VA(Camera) FDA UDIAC 100-240 V, 50/60 Hz, 61-94VA FDA UDIAC 100-240V, 50/60HZ, 61-94VA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053094061 EUDAMEDFDA UDI08800053093767 EUDAMEDFDA UDI08800053053853 EUDAMEDFDA UDI08800053045049 EUDAMEDFDA UDI08800053093842 EUDAMEDFDA UDI08800053091244 EUDAMEDFDA UDI08800053053792 EUDAMEDFDA UDI08800053093774 EUDAMEDFDA UDI08800053094085 EUDAMEDFDA UDI08800053045056 EUDAMEDFDA UDI08800053045063 EUDAMEDFDA UDI08800053093644 EUDAMEDFDA UDI08800053093798 EUDAMEDFDA UDI08800053091237 EUDAMEDFDA UDI08800053093675 EUDAMEDFDA UDI08800053093866 EUDAMEDFDA UDI08800053096058 EUDAMED08800053093484 EUDAMED08800053099547 EUDAMED08800266945099 EUDAMED08800266946294 EUDAMED08800053094665 EUDAMED08800266947888 EUDAMED08800053099776 EUDAMED08800053099301 EUDAMED08800266944382 EUDAMED08800266947406 EUDAMED08800266945082 EUDAMED08800266940575 EUDAMED08800053099684 EUDAMED08800053098304 EUDAMED08800053097208 EUDAMED08800313237146 EUDAMED08800053096294 EUDAMED08800266944689 EUDAMED08800053096225 EUDAMED08800266944771 EUDAMED08800053096973 EUDAMED08800313237085 EUDAMED08800053097079 EUDAMED08800266945112 EUDAMED08800266945105 EUDAMED08800053097956 EUDAMED08800053098311 EUDAMED08800266943934 EUDAMED08800053097871 EUDAMED08800266949424 EUDAMED08800053093460 EUDAMED08800053097086 EUDAMED08800053053785 FDA UDI
- Basic UDI-DI
- 88000530STBD EUDAMED88000530M300DT EUDAMED88000530C600C4 EUDAMED88000530S200EY EUDAMED88000530LM400B7 EUDAMED88000530E100BR EUDAMED88000530LM200AV EUDAMED88000530S250FF EUDAMED88000530S300F5 EUDAMED88000530C500BX EUDAMED
- Direct Marketing DI
- 08800053091237 EUDAMED08800053096058 EUDAMED08800053045056 EUDAMED08800053093484 EUDAMED08800053099547 EUDAMED08800053053853 EUDAMED08800266945099 EUDAMED08800266946294 EUDAMED08800053094665 EUDAMED08800266947888 EUDAMED08800053045049 EUDAMED08800053093644 EUDAMED08800053099776 EUDAMED08800053099301 EUDAMED08800053093798 EUDAMED08800266944382 EUDAMED08800053093842 EUDAMED08800053093774 EUDAMED08800266947406 EUDAMED08800266945082 EUDAMED08800266940575 EUDAMED08800053099684 EUDAMED08800053098304 EUDAMED08800053097208 EUDAMED08800313237146 EUDAMED08800053096294 EUDAMED08800053094085 EUDAMED08800266944689 EUDAMED08800053096225 EUDAMED08800266944771 EUDAMED08800053096973 EUDAMED08800053091244 EUDAMED08800313237085 EUDAMED08800053097079 EUDAMED08800053093675 EUDAMED08800053093866 EUDAMED08800053093767 EUDAMED08800266945112 EUDAMED08800053094061 EUDAMED08800266945105 EUDAMED08800053097956 EUDAMED08800053098311 EUDAMED08800266943934 EUDAMED08800053097871 EUDAMED08800053045063 EUDAMED08800053053792 EUDAMED08800266949424 EUDAMED08800053093460 EUDAMED08800053097086 EUDAMED
- FDA Product Code
- FTD FDA UDIEAZ FDA UDIGDC FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMEDZ12010701 FIXED SCIALYTIC LAMPS EUDAMEDQ0199 ODONTOLOGY DEVICES - OTHER EUDAMEDZ12010702 MOBILE SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light system FDA UDILED dental light, line-powered FDA UDIElectromechanical operating table base FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI872.4630 FDA UDI878.4960 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDIFDA 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
S300 Series by Dentis Co. , Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (66)
- FDA UDI 9451611e-e650-4fd5-ada6-f6e6ee6c0241 33 fields · synced Aug 4, 2026
- FDA UDI 1ca1b43a-cfe3-4ab6-ad31-1c2056c85d0e 33 fields · synced May 24, 2026
- FDA UDI ced1606b-39ea-40eb-aa1d-9c7cbae6451f 33 fields · synced May 25, 2026
- FDA UDI 6a05813d-904f-453d-9541-a9c901ada34a 33 fields · synced May 25, 2026
- FDA UDI caed5667-27df-454c-9010-85eece96c8c5 33 fields · synced May 30, 2026
- FDA UDI 2ce1034a-a548-4ffb-bbf5-515aaeaf9aa1 33 fields · synced May 30, 2026
- FDA UDI b110d271-4594-4c6a-b3f7-77e3f6690c6d 33 fields · synced May 30, 2026
- FDA UDI d1f6528c-614c-4a9f-a986-10ff56cf7ecb 33 fields · synced May 30, 2026
- FDA UDI 574a266f-ffde-4a26-9312-5209a12dc06a 33 fields · synced May 30, 2026
- FDA UDI 0453426a-9b29-489f-905c-0489a79503c3 33 fields · synced May 30, 2026
- FDA UDI a14496a1-bd28-4d36-9992-c7baa3b8c75f 33 fields · synced May 30, 2026
- FDA UDI de43063e-f551-43ad-af14-360c1573430e 33 fields · synced May 30, 2026
- FDA UDI 37bd0e55-9f11-4bd5-8aeb-606b47ac1176 33 fields · synced May 30, 2026
- FDA UDI 66d2de10-144d-46e8-ab9e-9e33a5fc198a 33 fields · synced May 30, 2026
- FDA UDI f531b037-56e8-4a96-8e0d-1a9b91e9a8c5 33 fields · synced May 30, 2026
- FDA UDI e4e95a17-4d31-49f2-ada8-fae895acebb2 33 fields · synced May 30, 2026
- FDA UDI 70304005-5be5-47ca-ab1d-af07dc0e8478 33 fields · synced May 30, 2026
- EUDAMED 6525dc4a-8412-448d-871d-14800084fe9d 61 fields · synced Jun 20, 2026
- EUDAMED 760f5ce0-7b2d-4eac-af2b-2cd8a9fbde6f 61 fields · synced Jul 8, 2026
- EUDAMED 62bf0b5d-91a3-4862-b79a-3e17b86c8f38 61 fields · synced Jul 9, 2026
- EUDAMED 71a657dc-429b-4bda-89b5-5f0c5c293ad5 61 fields · synced Jul 9, 2026
- EUDAMED b16c5da1-73fe-46e9-af88-cdc993bb9f6a 61 fields · synced Jul 9, 2026
- EUDAMED 3c721e9e-181d-40dc-ba1a-fdc968fdc0bc 61 fields · synced Jul 9, 2026
- EUDAMED 322ab720-56ad-480d-9eb1-452477b976ff 61 fields · synced Jul 9, 2026
- EUDAMED 50645f74-66cf-48fd-a27e-9ea830bc33ba 61 fields · synced Jul 9, 2026
- EUDAMED ea85b510-ed77-48ad-88a8-eabb0593384b 61 fields · synced Jul 9, 2026
- EUDAMED bf511bc9-15f3-4cf5-823d-ea64b76ba6f1 61 fields · synced Jul 9, 2026
- EUDAMED c540d0b7-42f2-4bb1-816a-a591e613d941 61 fields · synced Jul 9, 2026
- EUDAMED ce72fa88-dcc2-4a66-9808-028d11a234da 61 fields · synced Jul 10, 2026
- EUDAMED 324b6e2f-77ee-4939-9bc6-06333bd11fe0 61 fields · synced Jul 10, 2026
- EUDAMED 41fb9a36-d9a6-44db-9f96-1715d9570746 61 fields · synced Jul 10, 2026
- EUDAMED 6d900b01-219e-456e-a26b-9d4463e7fef9 61 fields · synced Jul 11, 2026
- EUDAMED caeb7e10-bba5-459d-af89-afb889ceede1 61 fields · synced Jul 11, 2026
- EUDAMED 1a397c6a-5538-4c89-afd9-747fbaf37582 61 fields · synced Jul 12, 2026
- EUDAMED 7a587fce-b3a9-47e4-acc1-ac191889d3a3 61 fields · synced Jul 12, 2026
- EUDAMED 3389d97e-0cc8-4298-8f2a-29597f3bbdd1 61 fields · synced Jul 12, 2026
- EUDAMED fc13c0b2-c61d-492d-8662-26fd6a10a206 61 fields · synced Jul 12, 2026
- EUDAMED c5ef539b-773c-43b4-807d-3fbe81aedbf1 61 fields · synced Jul 13, 2026
- EUDAMED a0c32a50-7d53-46b7-9295-f70e21891e7c 61 fields · synced Jul 13, 2026
- EUDAMED aed629fe-8a01-4bb0-86c1-adcea762849a 61 fields · synced Jul 13, 2026
- EUDAMED 94ed41c0-f05b-4cf1-932e-1a2eb82a7712 61 fields · synced Jul 14, 2026
- EUDAMED 252a749e-a524-481f-87bd-70d620506791 61 fields · synced Jul 14, 2026
- EUDAMED ae204812-b76c-4675-afe6-d85247162681 61 fields · synced Jul 14, 2026
- EUDAMED 65567776-2b6a-43d3-8e42-6f775d53b9fa 61 fields · synced Jul 15, 2026
- EUDAMED 72a414e0-21d8-4f60-aff2-6862b44cb319 61 fields · synced Jul 16, 2026
- EUDAMED aa77fde2-d427-4d8c-9f8b-524502ac94d1 61 fields · synced Jul 17, 2026
- EUDAMED 37af2c9a-188d-442e-a19c-1b079d3df41a 61 fields · synced Jul 17, 2026
- EUDAMED b8da2fe4-7072-4a50-a7d1-315fa67d26a4 61 fields · synced Jul 17, 2026
- EUDAMED 0679bb3a-3884-430f-b497-c7137e4e3400 61 fields · synced Jul 17, 2026
- EUDAMED d085b3ca-69e1-4e61-a40a-85f188243741 61 fields · synced Jul 20, 2026
- EUDAMED 6eee8107-fd63-4abb-a880-d92e593b98ad 61 fields · synced Jul 21, 2026
- EUDAMED a7462ab7-f5a6-4b92-b673-6e2df31a3e3c 61 fields · synced Jul 21, 2026
- EUDAMED 433d51bb-08c0-42e5-b907-77b8eeb7f30d 61 fields · synced Jul 21, 2026
- EUDAMED 202f8624-a52f-4992-bff3-8938df7001da 61 fields · synced Jul 22, 2026
- EUDAMED 89298154-e8f7-41b8-a815-7e8a328d897f 61 fields · synced Jul 22, 2026
- EUDAMED a926701f-e764-4abc-9959-39bcbb311ef2 61 fields · synced Jul 23, 2026
- EUDAMED 181d984b-36d8-4365-b290-72dcf4e96407 61 fields · synced Jul 26, 2026
- EUDAMED 2f39ed87-2b2c-4102-9876-31d7639cb6b4 61 fields · synced Jul 26, 2026
- EUDAMED 8b206d7f-c83e-498d-b5bf-ed392160b035 61 fields · synced Jul 26, 2026
- EUDAMED bca76012-c9cb-47e5-8cb0-bc55861f4690 61 fields · synced Jul 27, 2026
- EUDAMED 4ebad7ea-e8ef-4ee7-a492-2fc352b5009c 61 fields · synced Jul 28, 2026
- EUDAMED 1756a71f-faf8-4cd4-83c1-719b90f723a0 61 fields · synced Jul 30, 2026
- EUDAMED 83012d1f-4217-4f5a-aa3c-e7d26a7a48f2 61 fields · synced Jul 31, 2026
- EUDAMED f2f8075e-b6d1-4770-92ad-bc0b87a2de3a 61 fields · synced Aug 1, 2026
- EUDAMED 765f5124-51f1-4916-9193-a6e7776058e2 61 fields · synced Aug 2, 2026
- EUDAMED b68d5898-c453-44a3-98ac-386b7de3a383 61 fields · synced Aug 4, 2026