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Lateral Flow (LF) Reader
EUDAMEDClass A (EU MDR)
Ref ATR-001Model InstrumentRef ATR-300
Identity
- Trade Name
- Lateral Flow (LF) Reader EUDAMEDLateral Flow (LF) Reader Plus EUDAMED
- Device Name
- Lateral Flow (LF) Reader EUDAMEDLateral Flow (LF) Reader Plus EUDAMED
- Model / Reference
- Instrument EUDAMEDATR-001 EUDAMEDATR-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277514910 EUDAMED06936983105712 EUDAMED
- Basic UDI-DI
- 6970277510002TYP EUDAMED6970277510002UYR EUDAMED
- Direct Marketing DI
- 06970277514910 EUDAMED06936983105712 EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Lateral Flow (LF) Reader by Hangzhou Alltest 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 | 6970277510002TYP | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 3681904f-238c-4950-bc98-e87423b0234c 61 fields · synced Jul 12, 2026
- EUDAMED 20e223b8-22ad-44c6-b5d4-57d4b64b7829 61 fields · synced May 18, 2026