FDA.reportPublic FDA data

OPCOM MEDICAL INC.

Matched from indexed company URL: OPCOM INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30330108583033010858OPCOM MEDICAL INC.1N2026-01-0112F, No.6, JianKang Rd., Zhonghe Dist., New Taipei City 23586, T New Taipei City TW 23586

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3282831502865216K242699Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)FGB2025-05-28
3282831419701300
3282831501232854
3282831545034789
3282831614849902
3282831836476767
3282832006774452
3282832053008662

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGB12025-05-28

GUDID#

Penguin ENT Scope model - Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses:Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion.Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems.Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene.Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.

OPCOM INC.

2024-12-20

Duck Intraoral camera model - Explore the infinite possibilities that the Duck dental examination series brings to home care:Duck dental mirrors can uncover hidden dental plaque, solve the problem of plaque accumulation, and display areas that require thorough brushing and flossing.Duck intraoral examination mirror monitors the evaluation of braces, implants, and dentures to confirm precise alignment and optimal cleanliness, serving as an early warning system for lesions, ulcers, and mysterious spotsThe Duck intraoral examination mirror can identify gum inflammation, detect bleeding, and detect abnormal conditions that may indicate gum disease.The Duck intraoral examination mirror will become your oral care mentor, uncovering the intricate veil inside your mouth.Duck dental endoscope enters the world of telemedicine. Obtain expert opinions by sharing images of cavities with dental professionals.

OPCOM INC.

2024-12-20

Penguin ENT Scope model - Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses:Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion.Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems.Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene.Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.

OPCOM INC.

2024-12-20

Duck Intraoral camera model - Explore the infinite possibilities that the Duck dental examination series brings to home care:Duck dental mirrors can uncover hidden dental plaque, solve the problem of plaque accumulation, and display areas that require thorough brushing and flossing.Duck intraoral examination mirror monitors the evaluation of braces, implants, and dentures to confirm precise alignment and optimal cleanliness, serving as an early warning system for lesions, ulcers, and mysterious spotsThe Duck intraoral examination mirror can identify gum inflammation, detect bleeding, and detect abnormal conditions that may indicate gum disease.The Duck intraoral examination mirror will become your oral care mentor, uncovering the intricate veil inside your mouth.Duck dental endoscope enters the world of telemedicine. Obtain expert opinions by sharing images of cavities with dental professionals.

OPCOM INC.

2024-12-20