MAPLe

Organization name

Novuqare Pelvic Health B.V.

SRN

NL-MF-000023101

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Netherlands; available across 12 countries total.

Trade name

MAPLe

UDI-DI code

08720299709201

Basic UDI-DI

B-08720299709201

Reference / catalog number

MPFT1436xxxx

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product 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

Additional information URL

https://www.novuqare.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U070399PELVIC FLOOR REHABILITATION DEVICES - OTHER