Identity
- Trade Name
- MeMed BV® EUDAMEDFDA UDI
- Generic Name
- Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid FDA UDI
- Device Name
- MeMed BV® EUDAMED
- Model / Reference
- FG10001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 17290018739010 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001873901CU EUDAMED
- Direct Marketing DI
- 17290018739010 EUDAMED
- 510(k) Number
- K210254 FDA UDI
- FDA Product Code
- QPS FDA UDI
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple cell-mediated host immune response marker IVD, chemiluminescent immunoassay, rapid 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
Yes
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
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® 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 | 729001873901CU | 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 0b0deff2-70e7-4b51-b4f4-c0aa3f665dd2 61 fields · synced Jun 18, 2026
- FDA UDI 8087f412-c968-43d2-a94b-20599b84756f 33 fields · synced May 30, 2026