Medical device manufacturer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. holds 160 FDA 510(k) clearances across 17 product codes. Median elapsed review time is 104 days. openFDA lists no recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 160
- Product codes
- 17
- Median review
- 104 days
- Recall records
- 0
How does FDA spell Shenzhen Mindray Bio-Medical Electronics Co., Ltd.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. | device/registrationlisting | normalised |
| Shenzhen Mindray Bio-Medical Electronics Co. | device/510k | normalised |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | device/510k | normalised |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | device/registrationlisting | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Shenzhen Mindray Bio-Medical Electronics Co., Ltd. file in?
17 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 83 | 81 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 23 | 152 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 11 | 28 days | |
| MSX | System, Network And Communication, Physiological Monitors | 7 | 146 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 7 | 167 days | |
| BSZ | Gas-Machine, Anesthesia | 6 | 255 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 | 16 days | |
| DQA | Oximeter | 4 | 104 days | |
| CAD | Vaporizer, Anesthesia, Non-Heated | 2 | 155 days | |
| CBK | Ventilator, Continuous, Facility Use | 2 | 265 days | |
| CFR | Hexokinase, Glucose | 2 | 193 days | |
| GKZ | Counter, Differential Cell | 2 | 160 days | |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 | 212 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 167 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 181 days | |
| JGS | Electrode, Ion Specific, Sodium | 1 | 120 days | |
| MNT | Sv70 Ventilator | 1 | 269 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Shenzhen Mindray Bio-Medical Electronics Co., Ltd. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Shenzhen Mindray Bio-Medical Electronics Co., Ltd. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | BSZ | 268 | |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | MHX | 127 | |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | IYN | 56 | |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | MHX | 202 | |
| K252182 | SV70 Ventilator (SV70) | MNT | 269 | |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | IYN | 142 | |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | IYN | 190 | |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | IYN | 143 | |
| K251820 | ViewMateTM Ultrasound System | IYN | 91 | |
| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) | IYN | 135 |
Source: openFDA device/510k · retrieved
Where is Shenzhen Mindray Bio-Medical Electronics Co., Ltd. registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Shenzhen Mindray Bio-Medical Electronics Co., Ltd. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.