← Back to catalogue
EliA Cardiolipin IgM Well
EUDAMEDFDA UDIClass B (EU MDR)
Ref 14-5530-01
by Phadia AB
Identity
- Trade Name
- EliA Cardiolipin IgM Well EUDAMEDFDA UDI
- Generic Name
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA Cardiolipin IgM EUDAMEDEliA Cardiolipin IgM Well FDA UDI
- Model / Reference
- 14-5530-01 EUDAMEDDECC055300 FDA UDI
- Description
- EliA Cardiolipin IgM Well FDA UDI
Identifiers
- Catalog Number
- DECC055300 FDA UDI
- Primary DI / UDI-DI
- 07333066014739 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0094MH EUDAMED
- 510(k) Number
- K091845 FDA UDI
- FDA Product Code
- MID FDA UDI
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
- GMDN Term
- Anticardiolipin antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5660 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
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EliA Cardiolipin IgM Well by Phadia AB — Class B — 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 | 7333066BUDI0094MH | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED 33312c8a-dd08-4919-9fac-d0aa18b2f6f2 61 fields · synced Jul 23, 2026
- FDA UDI 38a08faf-e955-4fa1-8543-43be2d55dedd 37 fields · synced May 30, 2026