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Liquid Based Cytology Reagent
EUDAMEDClass A (EU MDR)
Ref 300 tests/packageRef 200 tests/packageRef 100 tests/packageRef 500 tests/package
Identity
- Device Name
- Liquid Based Cytology Reagent EUDAMED
- Model / Reference
- 300 tests/package EUDAMED200 tests/package EUDAMED100 tests/package EUDAMED500 tests/package EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500931193 EUDAMED06948500931186 EUDAMED06948500931179 EUDAMED06948500931216 EUDAMED
- Basic UDI-DI
- 69485009LBP001ML EUDAMED
- Direct Marketing DI
- 06948500931193 EUDAMED06948500931186 EUDAMED06948500931179 EUDAMED06948500931216 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Liquid Based Cytology Reagent 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 | 69485009LBP001ML | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED c854c0bd-ec26-4930-aa71-44d5b8612118 61 fields · synced Oct 6, 2026
- EUDAMED ddab34f1-1ed1-43eb-923c-121a45c813ba 61 fields · synced May 17, 2026
- EUDAMED d3ab9e48-6899-4e1e-8151-6ede23947679 61 fields · synced May 18, 2026
- EUDAMED f36c31e9-b80b-489b-ae31-cde8aefef260 61 fields · synced May 18, 2026