Identity
- Device Name
- ZEN-PX4e EUDAMED
- Model / Reference
- ZEN-PX4e EUDAMED207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809244062063 EUDAMED
- Basic UDI-DI
- B-08809244062063 EUDAMED
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb 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
ZEN-PX4e by Genoray Co., Ltd. — Class IIb — 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-08809244062063 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED e738467c-657b-4907-a7f8-87111c40ce72 61 fields · synced Jul 26, 2026