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EnVision FLEX Wash Buffer (20x)
EUDAMEDClass A (EU MDR)
Ref K8007Model K800721-2
Identity
- Trade Name
- EnVision FLEX Wash Buffer (20x) EUDAMED
- Device Name
- EnVision FLEX Wash Buffer (20x) EUDAMED
- Model / Reference
- K800721-2 EUDAMEDK8007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572030591 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A024801NL 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
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
No
EUDAMED
EnVision FLEX Wash Buffer (20x) 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 | 570057P3007P3010A024801NL | 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 19c7567b-6498-4124-af32-f0224081ae5f 61 fields · synced Oct 6, 2026