Identity
- Device Name
- Liquid Based Cytology Reagent EUDAMED
- Model / Reference
- 10 tests/package EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948500931148 EUDAMED
- Basic UDI-DI
- 69485009LBP001ML EUDAMED
- Direct Marketing DI
- 06948500931148 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - 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
Category: Nucleic acid extraction/isolation kit IVD
Liquid Based Cytology Reagent by Guangzhou LBP Medicine Science & Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69485009LBP001ML | Class A | Unknown |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026786
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 09d7f39a-b9b7-4c7f-9ca9-f7725ec612e2 61 fields · synced Jun 18, 2026