Identity
- Trade Name
- STA® - Multi Hep Calibrator EUDAMEDFDA UDI
- Generic Name
- Heparin anti-Xa IVD, calibrator FDA UDI
- Device Name
- STA® - Multi Hep Calibrator EUDAMED
- Model / Reference
- 00348 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450003482 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607450CALS0004EW EUDAMED
- 510(k) Number
- K111822 FDA UDI
- FDA Product Code
- JIS FDA UDI
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
- GMDN Term
- Heparin anti-Xa IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 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
Yes
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
STA® - Multi Hep Calibrator by Diagnostica Stago — 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 | 3607450CALS0004EW | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 57783b51-7b30-4e91-82de-a223c8abfc03 61 fields · synced May 29, 2026
- FDA UDI 871750fa-e99c-43dd-9fec-50a54bf04217 34 fields · synced May 29, 2026