Identity
- Trade Name
- EliA M2 Well EUDAMEDFDA UDI
- Generic Name
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- EliA M2 EUDAMEDEliA M2 Well FDA UDI
- Model / Reference
- 14-5649-01 EUDAMEDDECC056490 FDA UDI
- Description
- EliA M2 Well FDA UDI
Identifiers
- Catalog Number
- DECC056490 FDA UDI
- Primary DI / UDI-DI
- 07333066014852 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0121LT EUDAMED
- 510(k) Number
- K141375 FDA UDI
- FDA Product Code
- DBM FDA UDI
- EMDN Code
- W0102100702 ANTI-MITOCHONDRIAL ANTIBODIES EUDAMED
- GMDN Term
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5090 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 M2 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 | 7333066BUDI0121LT | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED 5685570a-3058-4e30-80b2-5c2327ca140a 61 fields · synced Jun 18, 2026
- FDA UDI 6d61b437-be27-4bc0-a1f4-a166d58894a1 37 fields · synced May 30, 2026