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PathTezt Consumable - Preserved Cell Solutions

EUDAMED

Class A (EU MDR)

Ref PCS-200920 Model 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

by Biocytech Corporation Sdn Bhd

Identity

Trade Name
PathTezt Preserve Cell Solution 20ml (Methanol Based) EUDAMED
Device Name
PathTezt Consumable - Preserved Cell Solutions EUDAMED
Model / Reference
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 EUDAMED
PCS-200920 EUDAMED

Identifiers

Primary DI / UDI-DI
09551020410108 EUDAMED
Basic UDI-DI
955102041CellH2 EUDAMED
EMDN Code
W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED
Cyprus 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 - Preserved Cell Solutions 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 b9e247ec-03c6-418a-acc9-bf5ee19c7083 61 fields · synced Jul 11, 2026
  • EUDAMED c901ff21-c5be-487c-bc8a-56773cee0e10 61 fields · synced Jul 11, 2026