MAPLe
by Novuqare Pelvic Health B.V.
Ref MPFT1436xxxx, 68000104
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08720299709201 | Date10 Mar 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- MAPLe SystemMAPLe Probe
- Model / Reference
- MPFT1436xxxx, 68000104
- Primary DI / UDI-DI
- 08720299709201, 08720299709218
- Basic UDI-DI
- B-08720299709201, B-08720299709218
- EMDN Code
- U070399 Pelvic floor rehabilitation devices - other
- Device Class
- Class IIa
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- NL-MF-000023101
Properties
Other properties (10)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Incorporates Medicinal Product: No