FDA.reportPublic FDA data

zumax

Primary DI
06945095528432
Brand
zumax
Company
Zumax Medical Co., LTD
Model
CLS3050
Catalog number
820113-10104-000
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
PTZColposcope (And Colpomicroscope), Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTZColposcope (And Colpomicroscope), ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095528432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095528432069450955284326945095528432

GMDN Terms#

Term, Definition table
TermDefinition
ColposcopeAn electrically-powered instrument intended to be used for the visual examination and treatment of the female genitalia. It is placed directly at the opening of the vagina which is held open with an inserted speculum during colposcopy. The instrument has a light source and magnifying lenses that allow the physician to view the interior of the vagina, particularly the uterine cervix. This device is used to check for cervical cancer typically after an abnormal Papanicolaou test (PAP) or as a follow up procedure to view an abnormal area seen during an earlier gynaecological examination. During colposcopy, samples of tissue can be taken from the cervix for testing.

Regulatory Flags#

DUNS number
421348837
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095527749zumaxOMS3200228V3742-292026-07-06
06945095527756zumaxOMS3200228V3740-292026-07-06
06945095527763zumaxOMS3000 Pro820110-10152-0002026-07-06
06945095527787zumaxOMS3500237-04102026-07-06
06945095527794zumaxOMS2380820110-10154-0002026-07-06
06945095527817zumaxOMS3500820111-10105-0002026-07-06
06945095527848zumaxOMS2350230V0041-002026-07-06
06945095527879zumaxOMS3500 Max820111-10107-0002026-07-06
06945095527886zumaxOMS2350230-0047-002026-07-06
06945095527893zumaxOMS3500820111-10109-0002026-07-06
06945095527909zumaxOMS2050252V0742-R5-282026-07-06
06945095527916zumaxOMS2380283V2850-002026-07-06
06945095527954zumaxOMS3200832100053762-292026-07-06
06945095528005zumaxOMS3200Pro323V3842-002026-07-06
06945095528012zumaxOMS3200Pro323V375N-002026-07-06
06945095528029zumaxOMS2380820110-10169-0002026-07-06
06945095528036zumaxOMS3200321V0041-002026-07-06
06945095528043zumaxOMS2380820110-10171-0002026-07-06
06945095528050zumaxOMS3000 Pro227V374N-002026-07-06
06945095528067zumaxOMS3200Pro323V37602026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095528340zumaxZumax Medical Co., LTDPTZ2026-07-06
07290016976106Liger MedicalLIGER MEDICAL, LLCPTZ2026-06-02
00860005151004Liger MedicalLIGER MEDICAL, LLCPTZ2026-05-05
06944413848542UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-09-05
06944413848559UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-09-05
06944413826731UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-06-17
06944413826809UHD series Video ColposcopeEdan Instruments, Inc.PTZ2025-06-17
04250365176162ATMOSATMOS MedizinTechnik GmbH & Co. KGPTZ2024-11-27
04250365176179ATMOSATMOS MedizinTechnik GmbH & Co. KGPTZ2024-11-27
08436041580089OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580096OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580102OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580119OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08436041580126OptomicOPTOMIC ESPAÑA SAPTZ2024-07-18
08800126000050CervirayAIDOTPTZ2023-06-14
06944413808409Video ColposcopeEdan Instruments, Inc.PTZ2017-11-23
04953170331718Light guideOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331725Eyepiece shape TV mountOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331732Small trayOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331756COLPOSCOPE OCS-500 SYSTEM RACKOLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21
04953170331770COLPOSCOPE OCS-500 DIGITAL CAMERA ADAPTEROLYMPUS MEDICAL SYSTEMS CORP.PTZ2016-09-21