Identity
- Trade Name
- SW MAGELLAN V7.XSTD EUDAMEDMAGELLAN FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Magellan V7.x EUDAMEDReader control and data reduction software for Tecan Microplate Reader. FDA UDI
- Model / Reference
- Standard EUDAMED30183889 EUDAMEDMAGELLAN V7.X FDA UDI
- Description
- Reader control and data reduction software for Tecan Microplate Reader. FDA UDI
Identifiers
- Catalog Number
- 30183889 FDA UDI
- Primary DI / UDI-DI
- 09120052070996 EUDAMEDFDA UDI
- Basic UDI-DI
- 912005207IVS10090000APE EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W0201020292 LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sw Magellan V7.xstd by Tecan Austria GmbH — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 912005207IVS10090000APE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tecan Austria GmbH
- EUDAMED SRN
- AT-MF-000020241
Sources (2)
- EUDAMED d360fb79-e967-438f-8982-c5ae4401794c 61 fields · synced Jun 19, 2026
- FDA UDI 3d328d82-b271-4452-b88e-296b2d08c649 35 fields · synced May 30, 2026