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Auffer
EUDAMEDClass A (EU MDR)
Ref 679005Model 480 mL, 6×480 mL, 2×2 L, 2×1 L, 4×1 L, 4×2 LRef 0320501806Ref 0320501805
Identity
- Trade Name
- Auffer EUDAMED
- Device Name
- Auffer EUDAMED
- Model / Reference
- 480 mL, 6×480 mL, 2×2 L, 2×1 L, 4×1 L, 4×2 L EUDAMED679005 EUDAMED0320501806 EUDAMED0320501805 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341680862 EUDAMED06978139070918 EUDAMED06978139070857 EUDAMED
- Basic UDI-DI
- 69703416803205064JM EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDNorthern Ireland 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
Auffer by Shenzhen Lifotronic Technology 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 | 69703416803205064JM | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED f4063728-98ca-4cf4-93dc-b712e2c074f5 61 fields · synced Aug 1, 2026
- EUDAMED 1484adf3-4358-405c-9a30-2ca9b9259173 61 fields · synced May 17, 2026
- EUDAMED bb061f17-2539-4c82-ad8c-271040c2d50b 61 fields · synced May 18, 2026