Identity
- Trade Name
- PYLCLARI AI EUDAMED
- Device Name
- PYLCLARI AI EUDAMED
- Model / Reference
- 802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350002338025 EUDAMED
- Basic UDI-DI
- 73500023383S EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pylclari Ai by Exini Diagnostics Ab — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73500023383S | Class IIa | Active |
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Manufacturer
- Manufacturer
- EXINI Diagnostics AB
- EUDAMED SRN
- SE-MF-000001840
Sources (1)
- EUDAMED 12e14d37-44a8-46dc-9e45-48e113b06a3a 61 fields · synced Jun 18, 2026