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BioCLIA Allergy Specific IgE Conjugate and Microparticle Set
EUDAMEDClass IVD General (EU MDR)
Ref MY01314Model 300 Tests/KitRef MY01311Model 100 Tests/KitRef MY01313Model 200 Tests/Kit
Identity
- Trade Name
- BioCLIA Allergy Specific IgE Conjugate and Microparticle Set EUDAMED
- Device Name
- BioCLIA Allergy Specific IgE Conjugate and Microparticle Set EUDAMED
- Model / Reference
- 300 Tests/Kit EUDAMEDMY01314 EUDAMED100 Tests/Kit EUDAMEDMY01311 EUDAMED200 Tests/Kit EUDAMEDMY01313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924030410582 EUDAMED06924030410551 EUDAMED06924030410575 EUDAMED
- Basic UDI-DI
- B-06924030410582 EUDAMEDB-06924030410551 EUDAMEDB-06924030410575 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
No
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
BioCLIA Allergy Specific IgE Conjugate and Microparticle Set by HOB Biotech Group Corp., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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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-06924030410582 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- HOB Biotech Group Corp., Ltd.
- EUDAMED SRN
- CN-MF-000023974
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 6c7467c9-83ff-4211-9d37-2e606f5d9785 61 fields · synced Jul 14, 2026
- EUDAMED b6dc34eb-90a7-45cf-8fe3-832d96eab215 61 fields · synced May 18, 2026
- EUDAMED acf1e10d-beec-4b3a-a745-0787f0121ee2 61 fields · synced May 19, 2026