Identity
- Trade Name
- MINICAP Hb A1c EUDAMEDFDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
- Device Name
- MINICAP Hb A1c EUDAMEDMeasure HbA1c from whole blood using a Capillary instrument FDA UDI
- Model / Reference
- 2215 EUDAMEDFDA UDI
- Description
- Measure HbA1c from whole blood using a Capillary instrument FDA UDI
Identifiers
- Catalog Number
- 2215 FDA UDI
- Primary DI / UDI-DI
- 03607360022153 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607362215BUBY EUDAMED
- FDA Product Code
- JJX FDA UDIJIS FDA UDILCP FDA UDI
- EMDN Code
- W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1150 FDA UDI864.7470 FDA UDI
- Market of Registration
- France 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
No
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
Yes
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
Yes
FDA UDI
MINICAP Hb A1c by Sebia — Class C — 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 | 3607362215BUBY | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- sebia
- EUDAMED SRN
- FR-MF-000003520
Sources (2)
- EUDAMED 348c0f77-1600-4e26-ad08-40e29a82d75d 61 fields · synced Jul 11, 2026
- FDA UDI 27559757-e79f-4d48-8e4b-8fff1085ed59 35 fields · synced May 29, 2026