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PathTezt Dual Filter

by Biocytech Corporation Sdn Bhd

Ref DF-2508Model 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number955102041FilterXS Basic UDI-DI 09551020410313UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09551020410313 UDI-DI Date11 Mar 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 Dual Filter EUDAMED
PathTezt® GUDID
Generic Name
Cytology specimen filter IVD
Device Name
PathTezt Consumable - Filter
Model / Reference
1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508, DF-2508
Primary DI / UDI-DI
09551020410313
Basic UDI-DI
955102041FilterXS
FDA Product Code
KET
EMDN Code
W05030402 Cell and tissue cultures, filters
GMDN Term
Cytology specimen filter IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.3010
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
MY-MF-000047354
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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