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PathTezt Consumable - Filter

EUDAMED

Class A (EU MDR)

Ref GF-0825100 Model 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508Ref L-30Model 1. L-30 2. LJ-30 3. LBP-2010 4. LBP-2012

by Biocytech Corporation Sdn Bhd

Identity

Device Name
PathTezt Consumable - Filter EUDAMED
Staining Consumable EUDAMED
Model / Reference
1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508 EUDAMED
GF-0825100 EUDAMED
1. L-30 2. LJ-30 3. LBP-2010 4. LBP-2012 EUDAMED
L-30 EUDAMED

Identifiers

Primary DI / UDI-DI
09551020410405 EUDAMED
09551020410702 EUDAMED
Basic UDI-DI
955102041FilterXS EUDAMED
955102041StainingJL EUDAMED
EMDN Code
W05030402 CELL AND TISSUE CULTURES, FILTERS EUDAMED
W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

PathTezt Consumable - Filter by Biocytech Corporation Sdn Bhd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

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

Sources (3)

  • EUDAMED 368287af-b1fe-4da0-a856-4ed132353152 61 fields · synced Jul 9, 2026
  • EUDAMED d1c1e60a-2869-43d2-a2b7-bb5ebdfbe6a8 61 fields · synced May 19, 2026
  • EUDAMED 6e166277-4564-4e22-99ed-33a7e2263e7c 61 fields · synced Jul 9, 2026