Identity
- Trade Name
- Medical Diagnostic X-Ray Equipment EUDAMED
- Device Name
- Medical Diagnostic X-ray Equipment EUDAMED
- Model / Reference
- PLD6500C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974265031526 EUDAMED
- Basic UDI-DI
- B-06974265031526 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL 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
Category: Stationary basic diagnostic x-ray system, digital
Medical Diagnostic X-Ray Equipment by Zhuhai Perlead Medical Equipment Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06974265031526 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhuhai Perlead Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000025749
- Authorised Representative
- BioDomi GmbH DE-AR-000016611
Sources (1)
- EUDAMED 07be1112-41fd-4d18-9985-24c55250fbb4 61 fields · synced Jun 18, 2026