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PathTezt Consumable - Slide

EUDAMED

Class A (EU MDR)

Ref CS-36100 Model 1. CS-36100 2. IS-36100 3. US-36100 4. HS-36100 5. CG-102450 6. GS-2500Ref GF-0825100Model 1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508

by Biocytech Corporation Sdn Bhd

Identity

Trade Name
PathTezt Gyn Filter EUDAMED
Device Name
PathTezt Consumable - Slide EUDAMED
PathTezt Consumable - Filter EUDAMED
Model / Reference
1. CS-36100 2. IS-36100 3. US-36100 4. HS-36100 5. CG-102450 6. GS-2500 EUDAMED
CS-36100 EUDAMED
1. GF-0825100 2. NGF-0525100 3. UCF-0813100 4. PS-250 5. DF-2508 EUDAMED
GF-0825100 EUDAMED

Identifiers

Primary DI / UDI-DI
09551020410504 EUDAMED
Basic UDI-DI
955102041SlideQL EUDAMED
955102041FilterXS EUDAMED
EMDN Code
W0503900201 MICROSCOPE SLIDES EUDAMED
W05030402 CELL AND TISSUE CULTURES, FILTERS EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED
Italy 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 - Slide 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

Manufacturer
Biocytech Corporation Sdn Bhd
EUDAMED SRN
MY-MF-000047354
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 989a1829-15b7-4bbc-aef0-98d6ad4b64b0 61 fields · synced Jul 28, 2026
  • EUDAMED 40df5b8d-039f-4645-a1b6-74a14f1f7f34 61 fields · synced Jul 28, 2026