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PathTezt Density Reagent
EUDAMEDClass A (EU MDR)
Ref PDR-1000Model 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 Density Reagent 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 EUDAMEDPDR-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410146 EUDAMED
- Basic UDI-DI
- 955102041CellH2 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- 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 Density Reagent 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 b4e964e8-9922-4b93-87be-79e3f5250145 61 fields · synced Jul 29, 2026