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PathTezt Processor
EUDAMEDClass A (EU MDR)
Ref LBC-2010Model 1. LBC-2009 2. PTIA-2021
Identity
- Device Name
- PathTezt Processor EUDAMED
- Model / Reference
- 1. LBC-2009 2. PTIA-2021 EUDAMEDLBC-2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551020410009 EUDAMED
- Basic UDI-DI
- 955102041ProcessorLR EUDAMED
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
New Device
No
EUDAMED
PathTezt Processor 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 | 955102041ProcessorLR | 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 cc44e3b5-d67f-4fa6-9e4a-7ae7a1c5a73b 61 fields · synced Jun 18, 2026