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Dako EnVision+ System- HRP Labelled Polymer Anti-mouse
EUDAMEDClass A (EU MDR)
Ref K4001Model K400111-2
Identity
- Trade Name
- Dako EnVision+ System- HRP Labelled Polymer Anti-mouse EUDAMED
- Device Name
- Dako EnVision+ System- HRP Labelled Polymer Anti-mouse EUDAMED
- Model / Reference
- K400111-2 EUDAMEDK4001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05700571104170 EUDAMED
- Basic UDI-DI
- 570057P3007P3010A052501NQ EUDAMED
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) 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
Dako EnVision+ System- HRP Labelled Polymer Anti-mouse by Agilent Technologies, Inc. — 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 | 570057P3007P3010A052501NQ | Class A | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
- EUDAMED SRN
- US-MF-000009385
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (1)
- EUDAMED 6f24d0d2-a168-4b72-81ef-c4cdb414a411 61 fields · synced Jun 19, 2026