Identity
- Device Name
- AAV5 DetectCDx™ Specimen Shipping Kit EUDAMED
- Model / Reference
- 56651 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860007476808 EUDAMED
- Basic UDI-DI
- 08600074768566519H EUDAMED
- EMDN Code
- W050299 DEVICES FOR SAMPLES TRANSPORT - 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
AAV5 DetectCDx™ Specimen Shipping Kit by ARUP Laboratories — 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 | 08600074768566519H | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ARUP Laboratories Inc
- EUDAMED SRN
- US-MF-000010117
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED ed40d67c-49c6-481f-8055-79b17f9121e1 61 fields · synced Jul 11, 2026