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LIA-ANA-Profile
EUDAMEDClass IVD General (EU MDR)
Ref L89401G6Ref L89401G3-2Ref T-L89401G2-2Ref L89401G1-2Ref L89401G5Ref L89401G4-2Ref T-L89401G4-2Ref L89401G2-2
Identity
- Trade Name
- LIA-ANA-Profile EUDAMED
- Device Name
- LIA-ANA-Profile EUDAMED
- Model / Reference
- L89401G6 EUDAMEDL89401G3-2 EUDAMEDT-L89401G2-2 EUDAMEDL89401G1-2 EUDAMEDL89401G5 EUDAMEDL89401G4-2 EUDAMEDT-L89401G4-2 EUDAMEDL89401G2-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-L89401G6VB EUDAMEDD-L89401G3-2ZS EUDAMEDD-T-L89401G2-234 EUDAMEDD-L89401G1-2ZG EUDAMEDD-L89401G5V9 EUDAMEDD-L89401G4-222 EUDAMEDD-T-L89401G4-23E EUDAMEDD-L89401G2-2ZM EUDAMED
- Basic UDI-DI
- B-L89401G6VB EUDAMEDB-L89401G3-2ZS EUDAMEDB-T-L89401G2-234 EUDAMEDB-L89401G1-2ZG EUDAMEDB-L89401G5V9 EUDAMEDB-L89401G4-222 EUDAMEDB-T-L89401G4-23E EUDAMEDB-L89401G2-2ZM EUDAMED
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
LIA-ANA-Profile by Shenzhen Yhlo Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-L89401G6VB | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (8)
- EUDAMED f5aca9fc-de27-4449-8f6e-f2681c314b58 61 fields · synced Aug 4, 2026
- EUDAMED 5ec86362-25bc-476c-ad7e-6ffd04ef328d 61 fields · synced May 16, 2026
- EUDAMED c2f3e2bd-d4d7-4773-847c-8ae588787e16 61 fields · synced May 17, 2026
- EUDAMED ef75e892-ec43-4f41-9147-dc491536bcf6 61 fields · synced May 17, 2026
- EUDAMED 2ad75b97-1975-4ce2-b0ff-d0022cb2bcfc 61 fields · synced May 18, 2026
- EUDAMED caf51daf-66e2-42b3-9aa3-e6a7268fb087 61 fields · synced May 18, 2026
- EUDAMED 995de31b-2d4d-4e29-8933-ee915204554d 61 fields · synced May 18, 2026
- EUDAMED d9f0184a-0c2a-4c47-89b3-0f3d42b1b2a8 61 fields · synced May 18, 2026