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PathTezt Preserve Cell Solution 5ml (Ethanol Based)
EUDAMEDClass A (EU MDR)
Ref PCS-200905EModel 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
Identity
- Trade Name
- PathTezt Preserve Cell Solution 5ml (Ethanol 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 EUDAMEDPCS-200905E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410474 EUDAMED
- Basic UDI-DI
- 955102041CellH2 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
PathTezt Preserve Cell Solution 5ml (Ethanol Based) 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 955102041CellH2 | Class A | Active |
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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 (1)
- EUDAMED ce157130-26ca-4620-87aa-159040f46de9 61 fields · synced Jul 30, 2026