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Specimen Diluent
EUDAMEDClass A (EU MDR)
Ref BCP.L.000499Model 1) 12 tests/bottle; 2) 100 tests/bottle
Identity
- Device Name
- Specimen Diluent EUDAMED
- Model / Reference
- 1) 12 tests/bottle; 2) 100 tests/bottle EUDAMEDBCP.L.000499 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500936204 EUDAMED
- Basic UDI-DI
- 69485009LBP004MS EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - 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
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
Specimen Diluent 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 | 69485009LBP004MS | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED ecae3d76-2195-4f76-841a-aa8f08e7a2ae 61 fields · synced Oct 6, 2026