Manufacturer registered with FDA
Suzhou Ramo Medical Instrument Co., Ltd.
Suzhou City, China. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 43
- 510(k) clearances
- 0as applicant
- Markets registered in
- 59 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Suzhou Ramo Medical Instrument Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Suzhou Ramo Medical Instrument Co., Ltd. | 7 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SUZHOU RAMO MEDICAL INSTRUMENT CO.,LTD | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SUZHOU RAMO MEDICAL INSTRUMENT CO., LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Suzhou RAMO Medical Instrument Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SUZHOU RAMO MEDICAL INSTRUMENT CO., LTD | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Suzhou Ramo Medical Instrument Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Probe CProbe FProbe S | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Rubber Dam | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Endo Holder | 2024 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Point | 2024 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Point | 2024 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | RCS Plugger | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | AP FileEndoViewFiles ProRCS Blue Orifice Opener FileRCS Blue Rotary FileRCS Blue T Reciprocating FileRCS BlueTRCS C FileRCS Children FileRCS Gold G Path Rotary FileRCS Gold LT Rotary File 25 moreRCS Gold Orifice Opener FileRCS Gold Rotary FileRCS GoldLTRCS GP FILERCS H FileRCS K FileRCS LT manual FileRCS Magic PathRCS ModiFileRCS Novel OneRCS R FileRCS Rainbow OneRCS Rainbow ONE FileRCS Rainbow UltraRCS Retreatment FileRCS SCLEANRCS Silver Deciduous Rotary FileRCS Silver G Path Rotary FileRCS Silver Orifice Opener FileRCS Silver Retreatment Rotary FileRCS Silver Rotary FileRCS SpreaderShape DSnake SystemUltrasonic Niti File | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUZHOU RAMO MEDICAL INSTRUMENT CO., LTD.FDA reg. 3021388085 | Suzhou City Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083781). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.