HeRO duet 3.1
by Medical Predictive Science Corp.
Ref 200000Model duet
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00865536000234 00865536000234 | Date1 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00865536000234 | Date29 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- HeRO EUDAMEDHeRO duet GUDID
- Generic Name
- Neonatal/paediatric heart rate monitoring application software
- Model / Reference
- duet EUDAMED200000 EUDAMED3.1 GUDID
- Primary DI / UDI-DI
- 00865536000234
- Basic UDI-DI
- B-00865536000234
- 510(k) Number
- FDA Product Code
- DPS
- EMDN Code
- V0299 Neonatology and paediatric devices - other
- GMDN Term
- Neonatal/paediatric heart rate monitoring application software
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 870.2340
- Special Device Type
- -1192
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | duet 200000 | 3.1 |
| Device Class | Class IIb | Class II |
Other devices from Medical Predictive Science Corp.
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Expiration Date: No