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Pax
EUDAMEDClass I (EU MDR)
Ref PANALEX 1(M)Model PANALEX-A、PANALEX-B、PANALEX-C、PANALEX-D、PANALEX-E、PANALEX 1、PANALEX 2、PANALEX 3、PANALEX 4、PANALEX 1(M)、PANALEX 1(W)、pax-XR1、pax-XR1 Pro、pax-XR1 Max、PAX-F700/700、PAX-F700/500、PAX-F700、PAX-F500
Identity
- Trade Name
- PAX EUDAMED
- Device Name
- Operating Light EUDAMED
- Model / Reference
- PANALEX-A、PANALEX-B、PANALEX-C、PANALEX-D、PANALEX-E、PANALEX 1、PANALEX 2、PANALEX 3、PANALEX 4、PANALEX 1(M)、PANALEX 1(W)、pax-XR1、pax-XR1 Pro、pax-XR1 Max、PAX-F700/700、PAX-F700/500、PAX-F700、PAX-F500 EUDAMEDPANALEX 1(M) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975678801089 EUDAMED
- Basic UDI-DI
- 697567880OL001QX EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Operating room light system
Pax by Shanghai PAX Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697567880OL001QX | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai PAX Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027540
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 050a9bca-164d-4da1-a1bd-864fc91ef774 61 fields · synced Jul 25, 2026