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PathTezt SelfSampler HPV Preserve Cell Solution 3ml
EUDAMEDClass A (EU MDR)
Ref SSH-1003Model 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 SelfSampler HPV Preserve Cell Solution 3ml 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 EUDAMEDSSH-1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410269 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
Yes
EUDAMED
PathTezt SelfSampler HPV Preserve Cell Solution 3ml 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 617ad304-c1e0-40ae-afac-98e9750db304 61 fields · synced Jun 18, 2026