← Back to catalogue
Flow Cell Recalibration Kit
EUDAMEDClass A (EU MDR)
Ref IVD-E-FRK01-RGLModel GridION Dx
Identity
- Trade Name
- Flow Cell Recalibration Kit EUDAMED
- Model / Reference
- GridION Dx EUDAMEDIVD-E-FRK01-RGL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056793800155 EUDAMED
- Basic UDI-DI
- 50567938OND-GRD-Dx1-RGLKR EUDAMED
- Direct Marketing DI
- 05056793800155 EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
New Device
Yes
EUDAMED
Flow Cell Recalibration Kit by Oxford Nanopore Diagnostics Limited — 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 | 50567938OND-GRD-Dx1-RGLKR | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxford Nanopore Diagnostics Limited
- EUDAMED SRN
- UK-MF-000046755
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED d1932173-fb02-4414-93da-9b8ea469636f 61 fields · synced Jun 18, 2026