← Back to catalogue
Diagnostic X-ray Unit
EUDAMEDClass IIb (EU MDR)
Ref PSK-CL-001Model HUM-20BT(VET-20BT)
Identity
- Device Name
- Diagnostic X-ray Unit EUDAMED
- Model / Reference
- HUM-20BT(VET-20BT) EUDAMEDPSK-CL-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800040900115 EUDAMED
- Basic UDI-DI
- B-08800040900115 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS 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
Diagnostic X-ray Unit by Poskom 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-08800040900115 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- POSKOM Co., Ltd.
- EUDAMED SRN
- KR-MF-000037452
- Authorised Representative
- medical ECONET GmbH DE-AR-000004983
Sources (1)
- EUDAMED 4346caaf-0db1-4511-a2b9-a260d262fad7 61 fields · synced Jun 19, 2026