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96‑Well Spectral Calibration Plate with NED Dye
EUDAMEDClass A (EU MDR)
Ref A26722
Identity
- Trade Name
- 96‑Well Spectral Calibration Plate with NED Dye EUDAMED
- Device Name
- Spectral Calibration Plates, a part of Calibration and Verification Plates EUDAMED
- Model / Reference
- A26722 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302014854 EUDAMED
- Basic UDI-DI
- 0190302TCF0000576BAM EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
96‑Well Spectral Calibration Plate with NED Dye by Life Technologies Holdings 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 | 0190302TCF0000576BAM | Class A | Active |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED dd185aa5-ec5b-46de-9372-dacd6db96347 61 fields · synced Aug 1, 2026