AvaMate
by MEDIGREIF Digital Health GmbH
Ref AVM-001Model AvaMate
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number426254635-AVAMARTE-7L 04262546350001 | Date7 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- AvaMate, AVM-001
- Primary DI / UDI-DI
- 04262546350001
- Basic UDI-DI
- 426254635-AVAMARTE-7L
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class I
- Special Device Type
- Software
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000051731
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