Identity
- Trade Name
- Sample Extraction Buffer EUDAMED
- Device Name
- Sample Extraction Buffer EUDAMED
- Model / Reference
- 1A0317-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963715951 EUDAMED
- Basic UDI-DI
- 692196371594JS EUDAMED
- Direct Marketing DI
- 06921963715951 EUDAMED
- EMDN Code
- W0104010805 BUFFERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Sample Extraction Buffer by Xiamen Boson Biotech Co., Ltd. — 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 | 692196371594JS | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fadea6c6-6478-4355-bc15-4446f06c9b81 61 fields · synced Jul 9, 2026