← Back to catalogue
IMMULITE 2000 Japanese hop Specific Allergen
EUDAMEDClass B (EU MDR)
Ref 10639221Model IVDR_67_LLB_DUB-C_B_REAG_Japanese hop Specific Allergen
Identity
- Trade Name
- IMMULITE 2000 Japanese hop Specific Allergen EUDAMED
- Device Name
- IVDR_67_LLB_DUB-C_B_REAG_Japanese hop Specific Allergen EUDAMED
- Model / Reference
- IVDR_67_LLB_DUB-C_B_REAG_Japanese hop Specific Allergen EUDAMED10639221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414986289 EUDAMED
- Basic UDI-DI
- 0405686900479VW EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
IMMULITE 2000 Japanese hop Specific Allergen by Siemens Healthcare Diagnostics Products Limited — Class B — IVDR — listed in EUDAMED
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
- e1 CLIA Microparticles — Autobio Diagnostics Co., Ltd. · 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
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 | 0405686900479VW | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- EUDAMED SRN
- GB-MF-000016339
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED c82cd866-fb4a-44f3-ad48-7e2d195cf691 61 fields · synced Jun 18, 2026