Heuron IPD
Ref H-PD-D05
Heuron IPD (H-PD-D05) is a medical device (EU MDR Class IIa) made by Heuron Co., Ltd., registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI B-08800086200033), active as of 25 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-08800086200033 08800086200033 | Date9 Apr 2026 | StatusActive |
| European Union | CE/MDD | NumberB-08800086200033 08800086200033 | Date9 Apr 2026 | StatusActive |
Official records
- EUDAMED public site B-08800086200033
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Model / reference
- H-PD-D05
- Primary DI / UDI-DI
- 08800086200033
- Basic UDI-DI
- B-08800086200033, 88000862PD01LJ
- EMDN code
- Z11069092 Various digital bioimaging management instruments - medical device software
- Device class
- Class IIa
- Special device type
- Software
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- GermanyFrance
Manufacturer details
- EUDAMED SRN
- KR-MF-000008614
- Authorised representative
- KTR Europe GmbH DE-AR-000005685
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