Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsScialytic lamp lighting systems
Scialytic lamp lighting systems - hardware accessories
EMDN code Z12010780
Manufacturers registered in Europe (EUDAMED) 16
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 59
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Aspen® Flexible Light Handle Adapter Aspen® Rigid Light Handle Adapter Aspen® Flexible Light Handle Cover Skytron Lumos Aspen® Rigid Light Handle Cover Skytron Flexible Light Handle Cover | K020304 (2002) |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal Burton Medical | registered |
| MAQUET GmbH Present in Europe in other categories | Germany | Maquet Sterigrip | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Olympus Gyrus ACMI | registered |
| VIDEOMED SRL Present in Europe in other categories | – | HELION | registered |
| XODUS MEDICAL, INC. Present in Europe in other categories | United States | Light Guard Flexible Light Handle Cover (3 Ea./pkg.) Light Guard™ Flexible Light Handle Cover (1 Each/pkg) Light Guard Semi-Rigid Light Handle Cover (1 Ea./pkg.) Light Guard Flexible Light Handle Cover (1 Ea./pkg.) Light Guard™ Flexible Light Handle Cover (2 Each/pkg) Light Guard™ Flexible Light Handle Cover (3 Each/pkg) | K053321 (2006) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| GRI Medical & Electronic Technology Co., Ltd. Present in Europe in other categories | China | Alleset Invenio B.braun | registered |
| SKYTRON LLC | United States | Center Focus Handle Skytron DoVera Positioning Handle Camera Cover Sterilizable Handle for DoVera DE12 Examination Light Series | registered |
| MEDICAL ACTION INDUSTRIES INC. | United States | Medical Action Industries Light Shield™ | registered |
| Microtek Medical LLC | United States | Skytron Lite-Lok Medline-Microtek Skytron® MICROTEK | registered |
| ALPHATEC SPINE, INC. | United States | Illico General Instrument | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Devon | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE INDUSTRIES Medline | K810292 (1981) |
| OWENS & MINOR DISTRIBUTION, INC. | – | Medichoice | registered |
| BLACK DIAMOND VIDEO, INC. | United States | HexaVue | K133413 (2014) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| RIMSA P. LONGONI SRL Present in Europe in other categories | Italy | STERILIZABLE HANDLE TVCC FOR UNICA/U29 STERILIZABLE HANDLE TVCC PREDISPOSITION FOR UNICA/U29 STERILIZABLE HANDLE FOR UNICA/U29 | registered |
| BR Surgical, LLC | – | BR Surgical, LLC | registered |
| AVID MEDICAL, INC. | – | AVID TruCustom | registered |
| SONY CORPORATION | Japan | SONY | registered |
| Supply Line Medical | – | Physician's Choice | registered |
| ALPHATEC HOLDINGS, INC. | United States | – | registered |
| Alleset, Inc. | United States | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Beijing Nubway S&T Co., Ltd. | China | – | registered |
| Bioana | Mexico | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| DKK DAI-ICHI SHOMEI CO, LTD | Japan | – | registered |
| Draegerwerk AG & CO Kgaa | Germany | – | registered |
| ECLIPSE PRISM MEDICAL DEVICES PVT. LTD | India | – | registered |
| ENDONEST MEDICAL SYSTEMS LLP | India | – | registered |
| GCMEDICA ENTERPRISE LTD.(WUXI) | China | – | registered |
| HAYCO MANUFACTURING LIMITED | China | – | registered |
| Henso Medical (Hangzhou) Co., Ltd. | China | – | registered |
| Heyuan Hong De Medical Products Co., Ltd. | China | – | registered |
| Imperial Trading Limited | Barbados | – | registered |
| Innopex Limited | Canada | – | registered |
| Nelipak Phoenix | United States | – | registered |
| New Pentastar Medical Products Co. Limited | Hong Kong SAR China | – | registered |
| O&M HALYARD, INC. | United States | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| Rongxing Plastic Jurong Co.,Ltd. | China | – | registered |
| S.I.M.E.O.N. Medical GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| SHANGHAI EVERPURE PLASTICS CO., LTD. | China | – | registered |
| SION BIOTEXT MEDICAL LTD | Israel | – | registered |
| SUZHOU JINGLE POLYMER MEDICAL APPARATUS | China | – | registered |
| SUZHOU JINSHENG PLASTIC CO., LTD. | China | – | registered |
| SUZHOU MECCAN IMP. & EXP. CORPORATION | China | – | registered |
| Shanghai Lejoy Co., LTD | China | – | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | – | registered |
| Toppan TEQ LLC | United States | – | registered |
| Trummed Medical (Hangzhou) Co.,Ltd. | China | – | registered |
| VINCENT MEDICAL MANUFACTURING CO., LTD. | Hong Kong SAR China | – | registered |
| Xodus Medical Shanghai | China | – | registered |
| ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
| ZHEJIANG HUANGYAN FEIDA PLASTIC PRODUCTS FACTORY | China | – | registered |
| guangdong fuqiang beauty equipment co.,Limited | China | – | registered |
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