General Meditech, Inc.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 4 products catalogued, 17 clearances.
General Meditech, Inc. is a complaint-file establishment holding a current FDA establishment registration. The registration covers Oximeter, Device, Iontophoresis, Other Uses and 1 other device type. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
Registration
| Registered name | GENERAL MEDITECH, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006147705 |
| FEI number | 3006147705 |
| DUNS | 545261786 |
| Establishment type | Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市杰纳瑞医疗仪器股份有限公司 |
|---|---|
| Unified social credit code | 91440300754296186P |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | South Office 4/F,Kezhi 1st.Rd west, |
| Postal code | 518057 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Device, Iontophoresis, Other Uses | Class 2 | 2015 | 2 | |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Class 2 | G3M, G3S, G3N, G3R, Model: G3C, G3D, G3F, G3G, G3H, G3L and G2A | 2010 | 9 |
| Oximeter | Class 2 | Model: G1B and G1B Plus | 2009 | 70 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Patient Monitor | MHX | 20 |
| Drionic TM | EGJ | 15 |
| Oximeter | DQA | 2 |
| Pulse Oximeter | DQA | 2 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K092970 | 2010-02-02 | MHX | Traditional | This company |
| K082789 | 2009-01-07 | DQA | Traditional | This company |
| K926269 | 1993-08-27 | LRO | Traditional | This company |
| K912975 | 1991-09-27 | KMJ | Traditional | This company |
| K912132 | 1991-08-07 | FHX | Traditional | This company |
| K903669 | 1990-09-12 | BSY | Traditional | This company |
| K900110 | 1990-05-02 | KMJ | Traditional | This company |
| K853635 | 1985-12-20 | EGJ | Traditional | This company |
| K844652 | 1984-12-12 | FSM | Traditional | This company |
| K831320 | 1983-07-19 | EGJ | Traditional | This company |
| K820689 | 1982-04-09 | FRG | Traditional | This company |
| K820521 | 1982-03-18 | FRG | Traditional | This company |
| K802231 | 1980-10-10 | BTM | Traditional | This company |
| K772089 | 1977-11-11 | EFQ | Traditional | This company |
| K770583 | 1977-05-26 | KXF | Traditional | This company |
| K770488 | 1977-05-23 | FYC | Traditional | This company |
| K770476 | 1977-05-06 | FME | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Patient monitors, Anesthesia monitors, Fetal-maternal monitors, ECG machines, Hemodynamic monitoring systems |
| Certifications | CFDA, CE, FDA, ANVISA, GOST |
| Export markets | 100+ countries worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.