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Flat Panel Detector
EUDAMEDClass IIa (EU MDR)
Ref Ref_Encoding rulesModel 4386Z
Identity
- Trade Name
- Flat Panel Detector EUDAMED
- Device Name
- Flat Panel Detector EUDAMED
- Model / Reference
- 4386Z EUDAMEDRef_Encoding rules EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976059770017 EUDAMED
- Basic UDI-DI
- 6976059774386ZC3 EUDAMED
- EMDN Code
- Z11079099 VARIOUS X–RAY FILM IMAGING SUPPORT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Flat Panel Detector by Shanghai PZ Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6976059774386ZC3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai PZ Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035699
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2705b16d-849a-4364-a0f5-712a1788cfaa 61 fields · synced Jun 18, 2026