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EnVision FLEX Mini Kit, High pH (Link)
EUDAMEDClass A (EU MDR)
Ref K8023Model K802321-2
Identity
- Trade Name
- EnVision FLEX Mini Kit, High pH (Link) EUDAMED
- Device Name
- EnVision FLEX Mini Kit, High pH (Link) EUDAMED
- Model / Reference
- K802321-2 EUDAMEDK8023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572030997 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A025201MV EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) 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
EnVision FLEX Mini Kit, High pH (Link) by Agilent Technologies Singapore (International) Pte Ltd — Class A — IVDR — listed in EUDAMED
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 | 570057P3007P3010A025201MV | 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 5c3d5f6c-a706-41a9-abd8-998c57321ff1 61 fields · synced Jun 18, 2026