Identity
- Trade Name
- Heuron IPD EUDAMED
- Device Name
- Heuron IPD EUDAMED
- Model / Reference
- H-PD-D05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800086200033 EUDAMED
- Basic UDI-DI
- B-08800086200033 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Heuron IPD by Heuron Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800086200033 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Heuron Co., Ltd.
- EUDAMED SRN
- KR-MF-000008614
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED c7f6a121-5166-4597-9e3b-33e7f9fe3152 61 fields · synced Jun 19, 2026