Identity
- Trade Name
- Phadia 5000 EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- Phadia Instruments EUDAMEDPhadia 5000 FDA UDI
- Model / Reference
- 12-4000-00 EUDAMEDFDA UDI
- Description
- Phadia 5000 FDA UDI
Identifiers
- Catalog Number
- 12-4000-00 FDA UDI
- Primary DI / UDI-DI
- 07333066001043 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0015LT EUDAMED
- 510(k) Number
- K051218 FDA UDI
- FDA Product Code
- DHB FDA UDI
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5750 FDA UDI
- Market of Registration
- Sweden 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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Phadia 5000 by Phadia AB — 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 | 7333066BUDI0015LT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED b2efc0f7-8434-49c7-90be-dcaa559c834f 61 fields · synced May 31, 2026
- FDA UDI 4275c81e-7aea-466c-9eb1-247beb08aaf3 36 fields · synced May 29, 2026