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zumax CLS3080

by Zumax Medical Co., LTD

Ref 830600050020-00

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69450955colposcope6Z Basic UDI-DI 06945095528999UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945095528999 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
CLS3080 EUDAMED
zumax GUDID
Generic Name
Colposcope
Device Name
Colposcope
Model / Ref / Catalog
830600050020-00, CLS3080
Primary DI / UDI-DI
06945095528999
Basic UDI-DI
69450955colposcope6Z
FDA Product Code
PTZ
EMDN Code
Z12020703 Colposcopes
GMDN Term
Colposcope
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.1630
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
830600050020-00
GUDID
CLS3080
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Zumax Medical Co., LTD

See all devices from Zumax Medical Co., LTD →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No