Identity
- Trade Name
- MeMed BV® External Control EUDAMEDFDA UDI
- Generic Name
- Multiple cell-mediated host immune response marker IVD, control FDA UDI
- Device Name
- MeMed BV® External Control EUDAMED
- Model / Reference
- FG12001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290018739034 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001873903CY EUDAMED
- Direct Marketing DI
- 17290018739034 EUDAMED
- 510(k) Number
- K210254 FDA UDI
- FDA Product Code
- QPS FDA UDI
- EMDN Code
- W01021521 MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS EUDAMED
- GMDN Term
- Multiple cell-mediated host immune response marker IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3215 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MeMed BV® External Control by Memed Diagnostics Ltd — 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 | 729001873903CY | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- MeMed Diagnostics Ltd.
- EUDAMED SRN
- IL-MF-000023622
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 6e35d189-3522-467c-baec-1e6789895bd0 61 fields · synced Jun 18, 2026
- FDA UDI 3ca5608d-1fd4-4dda-9818-5ae993faaaf8 33 fields · synced May 29, 2026