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Operating Lamp

by Nanjing Poweam Medical Co., Ltd 59 variants

Ref LED.MSTZ5Model LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697722645BTOL01QP Basic UDI-DI 06977226452606UDI-DIDate11 Apr 2024RegisteredStatusActive

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  • Withdrawn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

Model / Reference
LED.DTR78, LED.DTR78/DTR78, LED.D78, LED.D78/D78, LED.DT61/DT61, LED.DT61, LED.STZ5, LED.STZ5/STZ5, LED.STZ4, LED.STZ4/STZ4, LED.SZ4, LED.SZ4/SZ4, LED.MSTZ5, LED.MSTZ4, LED.MSZ4, LED.MD61, 01L.IILEDTR, 01L.IILED
Primary DI / UDI-DI
06977226452606
Basic UDI-DI
697722645BTOL01QP
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000040207
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Operating room light system

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: 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