Identity
- Trade Name
- SAMPLE CUP - BLUE EUDAMEDFDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- SAMPLE CUP EUDAMED
- Model / Reference
- A11A0176x EUDAMEDA11A01765 EUDAMED1220001765 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006702 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023sample_cup7S EUDAMED
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0503010280 SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES EUDAMED
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI
- Market of Registration
- France 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
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sample Cup - Blue by Horiba Abx Sas — 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 | 361023sample_cup7S | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED 70d45249-933e-4d67-97ca-c3f5715ccbcc 61 fields · synced Jul 25, 2026
- FDA UDI f599348f-3dd5-4c08-95e1-dcc56c665023 32 fields · synced May 30, 2026