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PathTezt® UCPCS-200920

by Biocytech Corporation Sdn. Bhd.

Ref UCPCS-200920Model 1. PCS-200920 2. PCS-200920E 3. PCS-200910 4. PCS-200910E 5. PCS-200910B 6. PCS-200905 7. PCS-200905E 8. PCS-200903 9. PCS-200903E 10. PCS-200901 11. PCS-200901E 12. SSH-1003 13. EV-60010 etc

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, self-declared

Class I: no certifier involved

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 Number09551020410436 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number955102041CellH2 Basic UDI-DI 09551020410436UDI-DIDate7 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
PathTezt UrineCell Preserve Cell Solution 20ml EUDAMED
PathTezt® GUDID
Generic Name
Cytology specimen container IVD, transport buffer
Device Name
PathTezt Consumable - Preserved Cell Solutions
Model / Reference
UCPCS-200920, 1. PCS-200920 2. PCS-200920E 3. PCS-200910 4. PCS-200910E 5. PCS-200910B 6. PCS-200905 7. PCS-200905E 8. PCS-200903 9. PCS-200903E 10. PCS-200901 11. PCS-200901E 12. SSH-1003 13. EV-60010 etc
Primary DI / UDI-DI
09551020410436
Basic UDI-DI
955102041CellH2
FDA Product Code
LEA
EMDN Code
W01030799 Histology / cytology reagents - other
GMDN Term
Cytology specimen container IVD, transport buffer
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
EU market of registration
Cyprus
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No