Bioscope Neuromonitor Device

The Bioscope Neuromonitor Device is intended to help surgeons in locating, identifying, and preserving cranial motor nerves during surgery, offering intra-operative monitoring and…

Registry build 21.09.26

The Bioscope Neuromonitor Device is intended to help surgeons in locating, identifying, and preserving cranial motor nerves during surgery, offering intra-operative monitoring and stimulation of peripheral motor nerves.

8manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (2), Jiangsu (2), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ETN
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Xian Friendship Medical Electronics Co., Ltd. Xi’An Shaanxi Contract manufacturer 10
Ningbo Shun YE Medical Company, Ltd. Cixi Ningbo Zhejiang Contract manufacturer 8
Shenzhen Launch Electrical Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Pine Moon Electronics Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Goals Sterilization Co., Ltd. Jiaxing Zhejiang Contract manufacturer 26
Changzhou Emanmed Biotechnology Co., Ltd. Changzhou Jiangsu Contract manufacturer 4

Record

Regulatory record for Bioscope Neuromonitor Device
Listed by Biosys Biyomedikal Muhendislik Sanayi VE Ticaret Anonim Sirketi, Türkiye
FDA product code ETN
Device type Stimulator, Nerve
Device class Class 2
Regulation 21 CFR 874.1820
Establishment Manufacturer
510(k) K233001
Record published 2026-06-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Storage environment temperature 10 to 40 °C; Storage environment humidity 0 to 90 % RH; Storage environment atmospheric pressure 700 to 1060 KiloPascal

Catalogue Numbers

Catalogue numbers for Bioscope Neuromonitor Device
Catalogue number Size Status
Bioscope In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ReLine Nuvasive, Inc. 226
Stimulator, Nerve Medtronic Xomed, Inc. 125
MaXcess Nuvasive, Inc. 95
Armada Nuvasive, Inc. 67
Stimulator, Nerve Neurovision Medical Products, Inc. 47
Precept Nuvasive, Inc. 39
MAS Plif Nuvasive, Inc. 36
NIM Medtronic Xomed, Inc. 34
Nerveana® Neurovision Medical Products, Inc. 30
SpheRx Nuvasive, Inc. 30
IOM Stimulator Probes Spes Medica Srl 29
NVM5 Nuvasive, Inc. 25

Showing 12 of 119. All products under Stimulator, Nerve

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer