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EnVision FLEX Antibody Diluent
EUDAMEDClass A (EU MDR)
Ref K8006Model K800621-2
Identity
- Trade Name
- EnVision FLEX Antibody Diluent EUDAMED
- Device Name
- EnVision FLEX Antibody Diluent EUDAMED
- Model / Reference
- K800621-2 EUDAMEDK8006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700572030584 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A024701NF 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
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 Antibody Diluent 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 | 570057P3007P3010A024701NF | 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 87956918-1f8a-4c9c-b6eb-1cd8f27076b2 61 fields · synced Jun 18, 2026