Identity
- Trade Name
- Buffer Solution EUDAMED
- Device Name
- Buffer Solution EUDAMED
- Model / Reference
- 5×TBE EUDAMED240401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931304663 EUDAMED
- Basic UDI-DI
- 695593130024040001JQ EUDAMED
- Direct Marketing DI
- 06955931304663 EUDAMED
- EMDN Code
- W0101070304 COMMON BUFFERS AND SOLUTIONS (ELECTROLYTES) 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
Buffer Solution by Yaneng BIOscience (Shenzhen) 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 | 695593130024040001JQ | Class A | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED ef8d75ea-de1f-4a89-8fbb-5f0b0c94b3e5 61 fields · synced Jun 18, 2026