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Operation Microscope

by Nanjing Poweam Medical Co., Ltd 14 variants

Ref OPT-1800EModel OPT-1000,OPT-2000,OPT-3000,OPT-4000, OPT-1000ent, OPT-1000,OPT-1200, OPT-1300E , OPT-1800E, OPT500E, OPT400E,JDY-I,JDY-II, JDY-Z,JDY-FHD, YDJ-FHD-1,DZY-16,DZY-16A,DZY-16B,JDY-12B, JDY-12BI, JDY-12B LED, JDY-12BI LED, JDY-12B II LED

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697722645BTOM01QU Basic UDI-DI 06977226452323UDI-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  • Withdrawn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
OPT-1000, OPT-2000, OPT-3000, OPT-4000, OPT-1000ent, OPT-1200, OPT-1300E, OPT-1800E, OPT500E, OPT400E, JDY-I, JDY-II, JDY-Z, JDY-FHD, YDJ-FHD-1, DZY-16, DZY-16A, DZY-16B, JDY-12B, JDY-12BI, JDY-12B LED, JDY-12BI LED, JDY-12B II LED
Primary DI / UDI-DI
06977226452323
Basic UDI-DI
697722645BTOM01QU
EMDN Code
Z12011101 Operative microscopes
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

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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