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Shadowless Operating Lamp

by Shanghai Huifeng Medical Instrument Co., Ltd. 42 variants

Ref /Model 700/500LED、500/500LED、700/700LED、SY02-LED3+5、SY02-LED3+3、 HF-L3+4CLED HF-L4+4CLED HF-L3+3CLED.etc

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 Number69457986HFSOL001KS Basic UDI-DI Date20 May 2022RegisteredStatusActive

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  • Withdrawn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
Shadowless Operating Lamp
Model / Reference
700/500LED、500/500LED、700/700LED、SY02-LED3+5、SY02-LED3+3、 HF-L3+4CLED HF-L4+4CLED HF-L3+3CLED.etc, /
Primary DI / UDI-DI
06945798677062, 06945798634096, 06945798625032, 06945798654117, 06945798675068, 06945798620044, 06945798677109, 06945798615040, 06945798677093, 06945798677055, 06945798641025, 06945798655046, 06945798654094, 06945798654018, 06945798677048, 06945798610038, 06945798612025, 06945798620068, 06945798634058, 06945798655053, 06945798620037, 06945798620075, 06945798634041, 06945798635055, 06945798641018, 06945798634027, 06945798628019, 06945798677031, 06945798675099, 06945798625025, 06945798615033, 06945798635017, 06945798620082, 06945798611028, 06945798625049, 06945798620020, 06945798655015, 06945798650010, 06945798628033, 06945798654100, 06945798655022, 06945798677024, 06945798640028, 06945798654049, 06945798675037, 06945798635062, 06945798654162, 06945798677017, 06945798634119, 06945798635048, 06945798654056
Basic UDI-DI
69457986HFSOL001KS
EMDN Code
Z12010701, Z12010702
Device Class
Class I
EU market of registration
France
Bulgaria
Poland
Hungary
Italy
Slovenia

Manufacturer details

EUDAMED SRN
CN-MF-000022480
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Operating room light system

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

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

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