← Back to catalogue
BioCLIA Allergy Reagent Kit, E5
EUDAMEDClass IVD General (EU MDR)
Ref MY01285Model E5, 50 Tests/KitRef MY01198Model E94, 50 Tests/Kit
Identity
- Trade Name
- BioCLIA Allergy Reagent Kit, E5 EUDAMED
- Device Name
- BioCLIA Allergy Reagent Kit EUDAMED
- Model / Reference
- E5, 50 Tests/Kit EUDAMEDMY01285 EUDAMEDE94, 50 Tests/Kit EUDAMEDMY01198 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030410292 EUDAMED06924030409418 EUDAMED
- Basic UDI-DI
- B-06924030410292 EUDAMEDB-06924030409418 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
BioCLIA Allergy Reagent Kit, E5 by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDD — 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
- Allergen Discs Serpula lacrymans — Gold Standard Diagnostics Kassel GmbH · IVD General
- ImmunoCAP Rare Allergen e217, Ferret epithelium — Phadia AB · Class B
- e1 CLIA Microparticles — Autobio Diagnostics Co., Ltd. · Class B
- Sharay Specific IgE (Mix of 22 items) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
- Sharay Specific IgE (19 Allergens) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
- IMMULITE®2000 Systems 3gAllergy™ Weed Panel 3 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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-06924030410292 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HOB Biotech Group Corp., Ltd.
- EUDAMED SRN
- CN-MF-000023974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 56ca51a3-9cc1-4c55-aad0-a6b33009fad6 61 fields · synced Jul 28, 2026
- EUDAMED 19097d79-2355-419c-b78f-302413947300 61 fields · synced May 17, 2026