Basic Information
- Primary DI
- 08800016000368
- Basic UDI-DI Code
- B-08800016000368
- Reference
- RF COMBO JECTOR
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- BOMTECH
Additional Description
- Intended Purpose This product is that injects a certain amount of medicine and delivers a high frequency to coagulation of tissue. - Configuration This device consists of Main body, Cradle, RF fixer and Adaptor. This product is intended to be used by charging battery (3.7 V 3000 mAh) inside the product through adapter (AC 100 240 V, 50/60 Hz, 0.5 0.3 A / DC 5 V, 3.0 A) and cradle. When charging with adapter, connect the adapter to the DC jack of the product and ch arge it. It consists of an LCD panel, control components, high frequency output section and multi needle. RF needle and Multi needles deliver high frequency energy to the human body and inject a certain amount of medicine. Bipolar electrode type RF needle and infusion multi needles are connected to the unit and used for coagulation and medicine delivery of patient tissue.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12030302 | SYRINGE PUMPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-386/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).