Manoa
Ref Manoa 5
Active
CE MDR
Valid until
25 Feb 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP13574PATHMATECOACH46 1313574MANOA5002 | Date1 Jul 2026 | StatusActive |
Certificates
- 1000216664 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 26 Feb 2026
- Expires
- 25 Feb 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pathmate Coach
- Model / Reference
- Manoa 5
- Primary DI / UDI-DI
- 1313574MANOA5002
- Basic UDI-DI
- PP13574PATHMATECOACH46
- EMDN Code
- V92 Medical device software - not included in other classes
- Device Class
- Class IIa
- Special Device Type
- Software
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000021685
- Authorised representative
- Pathmate Technologies GmbH DE-AR-000009101
Other devices from Pathmate Technologies AG
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No