Identity
- Trade Name
- Uricult Trio EUDAMEDUricult® Trio FDA UDI
- Generic Name
- Multiple formulation agar culture medium IVD FDA UDI
- Device Name
- Uricult Trio EUDAMEDA dip slide culture method for diagnosing urinary tract infections by demonstrating microbes in urine. FDA UDI
- Model / Reference
- 68197 EUDAMEDFDA UDI
- Description
- A dip slide culture method for diagnosing urinary tract infections by demonstrating microbes in urine. FDA UDI
Identifiers
- Catalog Number
- 68197 FDA UDI
- Primary DI / UDI-DI
- 06438115001485 EUDAMED06438115000044 FDA UDI
- Basic UDI-DI
- B-06438115001485 EUDAMED
- FDA Product Code
- JSI FDA UDI
- EMDN Code
- W0104010703 URINE SCREENING MANUAL (DIPSLIDES ETC.) EUDAMED
- GMDN Term
- Multiple formulation agar culture medium IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2360 FDA UDI
- Market of Registration
- Finland 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
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Uricult Trio by Aidian Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438115001485 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Aidian Oy
- EUDAMED SRN
- FI-MF-000023611
Sources (2)
- EUDAMED 125629cc-73cb-47a3-bf6d-5cc82cd8d74b 61 fields · synced Jul 11, 2026
- FDA UDI 4e03a4c2-f54f-40bb-aa6a-c416514a005c 36 fields · synced May 30, 2026