FDA.reportPublic FDA data

UHD series Video Colposcope

Primary DI
06944413826809
Brand
UHD series Video Colposcope
Company
Edan Instruments, Inc.
Model
C12 UHD
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
06944413826809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413826809069444138268096944413826809

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
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
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15
06944413866140Stimulation SystemPR382026-05-15
06944413866157Stimulation SystemPR4 Pro2026-05-15
06944413866164Stimulation SystemPR42026-05-15
06944413866171Stimulation SystemPA362026-05-15
06944413866188Stimulation SystemPA382026-05-15
06944413866195Stimulation SystemPA4 Pro2026-05-15
06944413866201Stimulation SystemPA42026-05-15
06944413866218Stimulation SystemQ32026-05-15
06944413866225Stimulation SystemQ92026-05-15
06944413866232Stimulation SystemQ102026-05-15
06944413866249Stimulation SystemQ122026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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