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Pax

by Shanghai PAX Medical Instrument Co., Ltd. China EUDAMED

Ref PANALEX-AModel 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

EMDN Z12010701

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697567880OL001QX Basic UDI-DIDate9 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Operating Light
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, PANALEX-A
Primary DI / UDI-DI
06975678801034
Basic UDI-DI
697567880OL001QX
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000027540
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Shanghai PAX Medical Instrument Co., Ltd.

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  • Pax

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  • Pax

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  • Pax

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  • Pax

    Class I

See all devices from Shanghai PAX Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 21804d39-33f8-4bf2-99b1-1facb5674188 61 fields · synced 22 Oct 2026