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EnVision FLEX+, Mouse, High pH (Link)
EUDAMEDClass A (EU MDR)
Ref K8002Model K800221-2
Identity
- Trade Name
- EnVision FLEX+, Mouse, High pH (Link) EUDAMED
- Device Name
- EnVision FLEX+, Mouse, High pH (Link) EUDAMED
- Model / Reference
- K800221-2 EUDAMEDK8002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572030553 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A024401MY 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+, Mouse, 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 | 570057P3007P3010A024401MY | 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 f624e52e-49f9-4735-8796-81362fa77804 61 fields · synced Jul 11, 2026