Identity
- Device Name
- Anode Buffer Container EUDAMEDAnode Buffer EUDAMED
- Model / Reference
- A02010014 EUDAMEDXB17034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937044500507 EUDAMED06937044500477 EUDAMED
- Basic UDI-DI
- 069370445abufcA02010003LJ EUDAMED069370445abufXB17024XE EUDAMED
- Direct Marketing DI
- 06937044500507 EUDAMED06937044500477 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Anode Buffer Container by Ningbo HEALTH Gene Technologies 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 | 069370445abufcA02010003LJ | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo HEALTH Gene Technologies Co., LTD.
- EUDAMED SRN
- CN-MF-000002278
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f8ee1189-f98d-4f39-b1cb-25701206f1b4 61 fields · synced Jun 20, 2026
- EUDAMED a806df1c-91cf-45f7-b403-3a99251ed6e9 61 fields · synced May 16, 2026