← Back to catalogue
t3 CLIA Microparticles
EUDAMEDClass B (EU MDR)
Ref CMQA2002Model AutoLumo Analyzers
Identity
- Trade Name
- t3 CLIA Microparticles EUDAMED
- Device Name
- t3 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo Analyzers EUDAMEDCMQA2002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359510615 EUDAMED
- Basic UDI-DI
- 697015090000251HB EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
t3 CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.
- IMMULITE®2000 Systems 3gAllergy™ Chicken Feathers — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ImmunoCAP Allergen c73, Insulin human — Phadia AB · Class B
- BioCLIA Allergy Reagent Kit, I6 — HOB Biotech Group Corp., Ltd. · IVD General
- Allergen Discs Serpula lacrymans — Gold Standard Diagnostics Kassel GmbH · IVD General
- ImmunoCAP Rare Allergen e217, Ferret epithelium — Phadia AB · Class B
- Sharay Specific IgE (Mix of 22 items) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
- BioCLIA Allergy Reagent Kit, F88 — HOB Biotech Group Corp., Ltd. · IVD General
- Sharay Specific IgE (19 Allergens) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
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 | 697015090000251HB | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 34f21aaf-aa4f-4cc2-975e-f8c2949bbf0d 61 fields · synced Jun 17, 2026