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LBC SD Testmate-4032
EUDAMEDClass A (EU MDR)
Ref Series D(100tests/box) ：CP.001.927Model "Series A(100tests/box) Series B(100tests/box) Series C(100tests/box) Series D(100tests/box) "Ref Series A(100tests/box) ：CP.001.924Ref Series C(100tests/box) ：CP.001.926Ref Series B(100tests/box) ：CP.001.925
Identity
- Device Name
- LBC SD Testmate-4032 EUDAMED
- Model / Reference
- "Series A(100tests/box) Series B(100tests/box) Series C(100tests/box) Series D(100tests/box) " EUDAMEDSeries D(100tests/box) ：CP.001.927 EUDAMEDSeries A(100tests/box) ：CP.001.924 EUDAMEDSeries C(100tests/box) ：CP.001.926 EUDAMEDSeries B(100tests/box) ：CP.001.925 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500937546 EUDAMED06948500937515 EUDAMED06948500937539 EUDAMED06948500937522 EUDAMED
- Basic UDI-DI
- 69485009LBP010MM EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMED
LBC SD Testmate-4032 by Guangzhou LBP Medicine Science & 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 | 69485009LBP010MM | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (4)
- EUDAMED 44d2c08b-092f-4c08-90e0-6c68cd6bc422 61 fields · synced Oct 6, 2026
- EUDAMED cec52a32-497d-46b8-8adb-a20c98ac8468 61 fields · synced May 19, 2026
- EUDAMED 9a409b53-39f3-409f-87d1-8b870602102e 61 fields · synced May 19, 2026
- EUDAMED 1f58fcb3-c2b4-4774-b8ca-54aabb1f1e46 61 fields · synced May 19, 2026