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Primostar 3

by Carl Zeiss Suzhou Co., Ltd. 11 variants

Ref 415501-0061-000Model Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1

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

CE IVDR

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
United StatesGUDID listing GUDID Number06909262200217 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number6909262CNA003QD Basic UDI-DI 06909262200217UDI-DIDate28 Jan 2023RegisteredStatusActive

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  • Withdrawn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/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Primostar 3 EUDAMED
ZEISS Primostar 3 GUDID
Generic Name
Basic light microscope
Device Name
Upright microscope
Model / Ref / Catalog
Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1, 415501-0061-000, Primostar 3
Primary DI / UDI-DI
06909262200217
Basic UDI-DI
6909262CNA003QD
Direct Marketing DI
06909262200217
FDA Product Code
MTX
EMDN Code
W0202050303 Optical laboratory microscopes
GMDN Term
Basic light microscope
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
884.6190
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Axioscope 5 / Axioscope 7/ Axiolab 5 / Primostar 3 / Primostar 1
415501-0061-000
GUDID
Primostar 3
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000017606
Authorised representative
Carl Zeiss Microscopy GmbH DE-AR-000024425

Other devices from Carl Zeiss Suzhou Co., Ltd.

See all devices from Carl Zeiss Suzhou Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No