MAPLe System
Basic Information
- Primary DI
- 08720299709201
- Basic UDI-DI Code
- B-08720299709201
- Reference
- MPFT1436xxxx
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Novuqare Pelvic Health B.V.
Additional Description
The MAPLe system is a medical device that is used by Pelvic Floor Physiotherapists for diagnosis and treatment of Pelvic Floor Dysfunction, it has two main functions: Electromyography (EMG) measurements and electro stimulation of the pelvic floor muscles. The MAPLe system consists of a single patient use probe, which is connected via a probe cable to a handheld. Pelvic Floor Physiotherapists will clean the MAPLe probe before and after use. The handheld is battery powered and contains the controlling electronics for EMG and electro stimulation. The handheld is charged on a docking station. MAPLe system is operated via a software application
CND Nomenclature Codes
| Code | Description |
|---|---|
| U070399 | PELVIC FLOOR REHABILITATION DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 2173979CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).