Identity
- Trade Name
- ASFA Scanner EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
- Device Name
- Immunofluorescence measuring device EUDAMEDASFA Scanner : Fluorescence scanner for cell analysis used for general cell-based biochemical analysis. FDA UDI
- Model / Reference
- MBD-SC4C-S EUDAMEDFDA UDI
- Description
- ASFA Scanner : Fluorescence scanner for cell analysis used for general cell-based biochemical analysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066300005 EUDAMEDFDA UDI
- Basic UDI-DI
- 8800066300005WS EUDAMED
- Direct Marketing DI
- 08800066300005 EUDAMED
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 711 Millimeter FDA UDIDepth — 534 Millimeter FDA UDIWidth — 834 Millimeter FDA UDI
ASFA Scanner by MBD CO., Ltd. — 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 | 8800066300005WS | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- MBD Co., Ltd.
- EUDAMED SRN
- KR-MF-000026682
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (2)
- EUDAMED 573412ea-e57a-4d9a-8852-49208fcf4cda 61 fields · synced Jun 19, 2026
- FDA UDI 6be46319-027e-4bde-9346-d4f2e2115481 36 fields · synced May 30, 2026