Labomed Prima Mu ENT Microscope
Labomed Prima Mu ENT microscope - '- MaxLite(TM) optics,3 step magnification: 0.6x, 1.0x, 1.6x - 27W LED illumination (cold light), 100V-240V AC universal power supply - Straight binocular…
Labomed Prima Mu ENT microscope – ‘- MaxLite(TM) optics,3 step magnification: 0.6x, 1.0x, 1.6x – 27W LED illumination (cold light), 100V-240V AC universal power supply – Straight binocular head, IPD 50-75mm – f=250mm CMO with manual fine focus knob and sterilizable cap – WF 10x/18mm eyepieces with foldable eyeguard – Swivel arm (380mm Long, 360° rotation), suspension arm (600mm Long, clockwise 70° and – 180° rotation) with locking/tension control knobs and LED shut-off in park position – Carrier arm and ± 155° coupling with tension adjustment locks – Floor stand with H-shape base on castor wheels with brakes – Yellow or Green filter, dust cover, and sterilizable knob caps
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu | Sichuan | Manufacturer | 1 |
| Hefei MAX ACT Medical Equipment Co., Ltd. | Hefei | Anhui | Manufacturer | 1 |
| Shanghai Eder Medical Technology Inc. | Shanghai | Shanghai | Manufacturer | 1 |
| Suzhou Semorr Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Labotech Microscopes India Private Limited, India |
|---|---|
| FDA product code | FSO |
| Device type | Microscope, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-14 |
| Record revised | 2026-07-20 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6212000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| zumax | Zumax Medical Co., Ltd. | 130 |
| MaxView System – Lateral Set | Viseon, Inc. | 7 |
| S100 / Opmi pico | Carl Zeiss Meditec Inc | 6 |
| S7 / Opmi PROergo | Carl Zeiss Meditec Inc | 6 |
| Aesculap | Aesculap AG | 4 |
| Atmos | Atmos Medizintechnik Gmbh & Co. KG | 4 |
| MaxView™ System – Lateral Set with Illumination | Viseon, Inc. | 3 |
| S7 / Opmi Sensera | Carl Zeiss Meditec Inc | 3 |
| Medical Microscope | Denjoy Dental Co., Ltd. | 3 |
| RoboticScope | Bhs Intl., Inc. | 2 |
| Rols Reinverter – Leica+ | Volk Optical Inc. | 2 |
| Rols Reinverter – Zeiss + | Volk Optical Inc. | 2 |
Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery
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.