Identity
- Trade Name
- STA® - Owren-Koller EUDAMEDFDA UDI
- Generic Name
- Buffered sample diluent IVD FDA UDI
- Device Name
- Owren-Koller Buffer EUDAMED
- Model / Reference
- 00360 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 13607450003601 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607450AUXI0001RL EUDAMED
- Unit of Use DI
- 03607450003604 EUDAMED
- FDA Product Code
- PPM FDA UDI
- EMDN Code
- W0103020903 BUFFERS (HAEMOSTASIS) EUDAMED
- GMDN Term
- Buffered sample diluent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
STA® - Owren-Koller by Diagnostica Stago — 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 | 3607450AUXI0001RL | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 8d5ed9b7-c4a7-4e16-ba21-90d5271b14d6 61 fields · synced Jun 18, 2026
- FDA UDI 4fac62d1-68fd-4a60-86cf-703ab643b410 33 fields · synced May 30, 2026