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PathTezt Cyto-Slide
EUDAMEDClass A (EU MDR)
Ref CS-36100Model 1. CS-36100 2. IS-36100 3. US-36100 4. HS-36100 5. CG-102450 6. GS-2500
Identity
- Trade Name
- PathTezt Cyto-Slide EUDAMED
- Device Name
- PathTezt Consumable - Slide EUDAMED
- Model / Reference
- 1. CS-36100 2. IS-36100 3. US-36100 4. HS-36100 5. CG-102450 6. GS-2500 EUDAMEDCS-36100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410092 EUDAMED
- Basic UDI-DI
- 955102041SlideQL EUDAMED
- EMDN Code
- W0503900201 MICROSCOPE SLIDES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- 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
Category: General specimen microscopy slide IVD, single-use
PathTezt Cyto-Slide by Biocytech Corporation Sdn Bhd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 955102041SlideQL | 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 fee3106c-f591-4de6-ba70-07b2cf249dc5 61 fields · synced Jun 18, 2026