SurgiTel
Optical assembly and light source for magnified view and more ergonomic posture for surgical and dental procedures.
2manufacturers in China registered for this device type
65catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Anco China Ltd | Hong Kong | Hong Kong | Exporter | 6 |
Record
| Listed by | Surgitel |
|---|---|
| FDA product code | HOH |
| Device type | Spectacle, Operating (Loupe), Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4770 |
| Premarket notification | Exempt |
| Record published | 2023-01-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVK450 TTL | In distribution | |
| MICRO250XF FLM | In distribution | |
| MICROEVK300 TTL | In distribution | |
| TTL Loupe, Wired Light | In distribution | |
| EVC250 FLM | In distribution | |
| EVC300 FLM | In distribution | |
| MICRO300N FLM | In distribution | |
| TTL Loupe | In distribution | |
| EVK650 FLM | In distribution | |
| Wired Light | In distribution | |
| EVC250XF FLM | In distribution | |
| EVC300XF FLM | In distribution | |
| EVKDEF450TTL | In distribution | |
| EVKDEF350TTL | In distribution | |
| EVX250N FLM | In distribution | |
| FLM Loupe, Wired Light | In distribution | |
| SurgiCam, Wireless Light | In distribution | |
| EVC250N FLM | In distribution | |
| MICROEVK450 TTL | In distribution | |
| EVK350 FLM | In distribution | |
| EVX250 FLM | In distribution | |
| MICRO250 FLM | In distribution | |
| MICROEVK350 FLM | In distribution | |
| Headband Loupe | In distribution | |
| MICROEVK450 FLM | In distribution | |
| EVX250 TTL | In distribution | |
| EVC300F FLM | In distribution | |
| EVK550 FLM | In distribution | |
| EVKDEF550TTL | In distribution | |
| TTL Loupe, Wireless Light | In distribution | |
| MICRO300 FLM | In distribution | |
| MICRO300 TTL | In distribution | |
| EVK550 TTL | In distribution | |
| Wireless Light | In distribution | |
| FLM Loupe | In distribution | |
| MICRO300XF FLM | In distribution | |
| Headband Loupe, Wired Light | In distribution | |
| EVKDEF650TTL | In distribution | |
| EVC300 TTL | In distribution | |
| EVK800 FLM | In distribution | |
| EVC300N FLM | In distribution | |
| EVC250 TTL | In distribution | |
| EVX250XF FLM | In distribution | |
| EVK350 TTL | In distribution | |
| MICRO250N FLM | In distribution | |
| FLM Loupe, Wireless Light | In distribution | |
| Surgical Mini LED | In distribution | |
| MICRO250F FLM | In distribution | |
| EVX250F FLM | In distribution | |
| EVC250M FLM | In distribution | |
| EVC300M FLM | In distribution | |
| MICROEVK300 FLM | In distribution | |
| EVK1000 FLM | In distribution | |
| EVC250F FLM | In distribution | |
| EVK1000 TTL | In distribution | |
| MICROEVK350 TTL | In distribution | |
| MICRO300F FLM | In distribution | |
| SurgiCam, Wired Light | In distribution | |
| EVK650 TTL | In distribution | |
| SurgiCam | In distribution | |
| EVK450 FLM | In distribution | |
| Headband Loupe, Wireless Light | In distribution | |
| EVK800 TTL | In distribution | |
| MICRO250 TTL | In distribution | |
| MICRO300M FLM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biom Optic Set disposable, with Biom HD Professional lens for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 2 |
| HNM Medical | HNM Stainless, LLC. | 1 |
| Biom Optic Set disposable, with Biom HD Flex lens for f=175 mm or f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready+ 175, for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready+ 200, for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom 6 HD Optic Set for f=175 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Biom ready disposable for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| EyeMag Classic | Carl Zeiss Meditec Inc | 1 |
| EyeMag Smart TTL | Carl Zeiss Meditec Inc | 1 |
| Biom 6 HD Optic Set for f=200 mm | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| HD Disposable LenZ | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| EyeMag Pro S | Carl Zeiss Meditec Inc | 1 |
Showing 12 of 15. All products under Spectacle, Operating (Loupe), Ophthalmic
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.