Identity
- Trade Name
- PNA ISH Detection Kit EUDAMED
- Device Name
- PNA ISH Detection Kit EUDAMED
- Model / Reference
- K520111-2 EUDAMEDK5201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572004486 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A022601MU EUDAMED
- EMDN Code
- W01030703 DNA IN SITU HYBRIDISATION REAGENTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
PNA ISH Detection Kit by Agilent Technologies Singapore (International) Pte Ltd — 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 | 570057P3007P3010A022601MU | Class A | Active |
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Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED eddf1283-e048-4d0d-ae72-0013d6d43245 61 fields · synced Jun 18, 2026