MD-320W Ultrasound Biomicroscope
Meda Co., LTD
MEDA CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006540052 | 3006540052 | MEDA CO., LTD. | 1 | N | 2026-01-01 | F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Skill Park Huayuan Industry Development Area Tianjin CN 300384 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 79533 | 1774669056 | K213070 | MD-320W Ultrasound Biomicroscope | IYO | 2021-11-18 |
| 79533 | 2011354324 | K182460 | MD-6000P Bladder Scanner | IYO | 2019-05-06 |
| 79533 | 1786193916 | K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | IYO | 2015-11-17 |
| 79533 | 1160779968 | K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | IYO | 2013-05-03 |
| 79533 | 1115276941 | K113304 | BLADDER SCANNER | IYO | 2012-03-23 |
| 79533 | 1475320424 | K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 | IYO | 2007-01-29 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYO | 6 | 2021-11-18 |
PMN#
MD-6000P Bladder Scanner
Meda Co., LTD
MD-2300S Ultrasonic A/B Scanner For Ophthalmology
MEDA CO.,LTD
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
MEDA CO. LTD.
BLADDER SCANNER
MEDA CO. LTD.
GUDID#
Ultrasound Biomicroscope - MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
2021-12-18
Bladder Scanner - MD-6000P Bladder Scanner is a hand-held ultrasonic equipment with built-in 3D mechanical sector scan probe. It is intended to measure the urine volume in human bladder. It can be connected with Tablet PC through Wi-Fi connection for medical record data transmission and management.
2019-07-01
Ultrasonic Pachymeter - MD-1000P Ultrasonic Pachymeter is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of corneal thickness.
2016-09-01
Ultrasonic Biometer for Ophthalmology - MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
2016-09-01
Ultrasonic A/B Scanner for Ophthalmology - ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
2016-09-01
Ultrasonic A/B Scanner for Ophthalmology - ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
2016-09-01
Ultrasonic A/B Scanner for Ophthalmology - MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
2016-09-01
Ultrasonic Biometer for Ophthalmology - MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.
2016-09-01
Bladder Scanner - MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It utilizes ultrasonic distance measuring principle to measure the volume of bladder filled with urine.
2016-09-01