Identity
- Trade Name
- VACUSERA EUDAMED
- Device Name
- VACUSERA® 10 ml Boric Acid Urine Tube EUDAMED
- Model / Reference
- 236840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- M7122368401 EUDAMED
- Basic UDI-DI
- B-M7122368401 EUDAMED
- EMDN Code
- W05010202 URINE COLLECTION, TUBES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Vacusera by Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-M7122368401 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Di̇sera Tibbi̇ Malzeme Loji̇sti̇k San. Ve Ti̇c. A.ş.
- EUDAMED SRN
- TR-MF-000025066
Sources (1)
- EUDAMED 9af12632-8555-478b-87e3-c1bf1b01ff04 61 fields · synced Jun 19, 2026