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ORAL-SKREEN Negative with Stabilizer, 500mL
EUDAMEDClass IVD General (EU MDR)
Ref 20200200
Identity
- Trade Name
- ORAL-SKREEN Negative with Stabilizer, 500mL EUDAMED
- Device Name
- SALIVABUSE LIQUID CONTROL ORAL FLUID EUDAMED
- Model / Reference
- 20200200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810042682665 EUDAMED
- Basic UDI-DI
- B-00810042682665 EUDAMED
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
ORAL-SKREEN Negative with Stabilizer, 500mL by Biochemical Diagnostics Inc — 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-00810042682665 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biochemical Diagnostics, Inc
- EUDAMED SRN
- US-MF-000025179
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED b6ca4beb-b586-4460-91dc-b9f2ac668f2f 61 fields · synced Aug 1, 2026