Identity
- Trade Name
- STANDARD™ i Wash buffer EUDAMED
- Device Name
- STANDARD™ i Wash buffer EUDAMED
- Model / Reference
- i-WBF-01 EUDAMED16WB10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111722677 EUDAMED
- Basic UDI-DI
- 88001117IPAA07IA01X8 EUDAMED
- Direct Marketing DI
- 08800111724367 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
STANDARD™ i Wash buffer by SD Biosensor Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88001117IPAA07IA01X8 | Class A | Active |
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Manufacturer
- Manufacturer
- SD Biosensor Inc.
- EUDAMED SRN
- KR-MF-000009168
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED a2a7b512-235f-48d6-bdf2-6366bc89fa35 61 fields · synced Jun 19, 2026