FDA.reportPublic FDA data

Mediworks

Primary DI
06945087515013
Brand
Mediworks
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
S150
Published
2022-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945087515013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087515013069450875150136945087515013

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527884077
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945087500262MediWorksDM3902026-10-09
06945087500439EssilorDS6502026-10-09
06945087565018EssilorSL6502022-11-02
06945087500057EssilorSL650+2022-11-02
06945087520000RodenstockRSL 21002021-05-17
06945087525005RodenstockRSL 26002021-05-17
06945087525012RodenstockRSL 2600digital2021-05-17
06945087590003TomeyTSL-900Z2021-05-17
06945087590010TomeyTSL-900H2021-05-17
06945087590027TomeyTSL-900Hdigital2021-05-17
06945087540015EssilorSL400H2021-05-10
06945087540022EssilorSL400L2021-05-10
06945087545010EssilorSL450H2021-05-10
06945087545027EssilorSL450L2021-05-10
06945087505175MediworksScansys TA5172020-03-12
06945087516225MediworksFC1622021-05-18
06945087500026MediworksSM6212022-11-02
06945087500040MediWorksS2902022-11-02
06945087500217MediWorksSL6502022-11-02
06945087530023MediworksSL300L2021-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977703380019Heidelberg RCMGaush Neotech Ltd.PUE2026-10-15
06977703380026Heidelberg RCMGaush Neotech Ltd.PUE2026-10-15
08437030208014CAPTURALIGHTFIELD MEDICAL EUROPE S.L.PUE2026-10-09
06975449020022SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020039SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020046SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06973211070930Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
08908006463497LABOMED SLx 40- 3 Step Slit lamp -HL (Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463503LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463510LABOMED SLx 40- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463527LABOMED SLx 45- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463534LABOMED eVO300 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463541LABOMED eVO400 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463558LABOMED eVO300 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463565LABOMED eVO400 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463589LABOMED eVO450 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463596LABOMED eVO350 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463602LABOMED eVO450 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
06972039971405MOPTIMShenzhen CERTAINN Technology Co., Ltd.PUE2022-12-08
07640132985610Imaging SetHaag-Streit AGPUE2022-11-22
07640132986549HeadrestHaag-Streit AGPUE2022-11-22