Identity
- Device Name
- Exdia PT10 EUDAMED
- Model / Reference
- PD-PT10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800026300229 EUDAMED
- Basic UDI-DI
- 88000263PDPT10FQ EUDAMED
- EMDN Code
- W0201010299 LIMITED PANEL CHEMISTRY ANALYSERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Exdia PT10 by Precision Biosensor Inc. — 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 | 88000263PDPT10FQ | Class A | Active |
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Manufacturer
- Manufacturer
- Precision Biosensor Inc.
- EUDAMED SRN
- KR-MF-000034861
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 525c79fa-d3e3-4a56-a950-43f172890efb 61 fields · synced Jul 26, 2026