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EL7010

by Zumax Medical CO., LTD.

Ref 701E5000

EL7010 (701E5000) is a Class I device made by Zumax Medical Co., LTD, registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 69450955ELG4), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69450955ELG4 Basic UDI-DI 06945095556459UDI-DIDate14 Oct 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
LED Examination Light
Model / reference
701E5000
Primary DI / UDI-DI
06945095556459
Basic UDI-DI
69450955ELG4
EMDN code
Z129004 Light sources
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011126
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

Other properties (14, all answered No)