Amedcon Medical Technology (Shenzhen) Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 7 device types.
Amedcon Medical Technology (Shenzhen) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mirror, Mouth, Probe, Periodontic and 5 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | AMEDCON MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008493350 |
| FEI number | 3008493350 |
| Establishment type | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Unit 201, Block 4, Meitai Industrial Park, 1231 Guanguang Road, |
| Postal code | 518110 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | EZ STENT; EZ Stopper; Thermoplastic Drill Template Set | 2015 | 70 |
| Explorer, Operative | Class 1 | EZ STENT; Thermoplastic Drill Template Set | 2013 | 8 |
| Handle, Instrument, Dental | Class 1 | 2013 | 29 | |
| Mirror, Mouth | Class 1 | 2013 | 94 | |
| Probe, Periodontic | Class 1 | 2013 | 34 | |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Empty Plastic Syringes for dental materials filling, Plastic Capillary tips, Plastic Syringe Caps | 2021 | 32 |
| Syringe, Restorative And Impression Material | Class 1 | Empty Plastic Syringes for dental materials filling, Dispensing Tips (plastic / metal), Plastic Syringe Caps, Plastic Intra Oral Tips | 2013 | 49 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Main products | Dental syringes, Delivery tips, Capsules and capsule dispensers, Syringe caps, Dental instruments |
| Certifications | ISO 13485:2016, ISO 14644-1:2015 Class 8, US FDA QMSR (21 CFR 820), EU MDR, KFDA/MFDS, PMDA, NMPA |
| Export markets | 15+ countries |
| OEM and ODM | Offered |
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.