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IMMULITE 2000 Argula Specific Allergen
EUDAMEDClass B (EU MDR)
Ref 10385821Model IVDR_67_LLB_DUB-C_B_REAG_Argula Specific Allergen
Identity
- Trade Name
- IMMULITE 2000 Argula Specific Allergen EUDAMED
- Device Name
- IVDR_67_LLB_DUB-C_B_REAG_Argula Specific Allergen EUDAMED
- Model / Reference
- IVDR_67_LLB_DUB-C_B_REAG_Argula Specific Allergen EUDAMED10385821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414972640 EUDAMED
- Basic UDI-DI
- 0405686900258VC 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 Argula Specific Allergen by Siemens Healthcare Diagnostics Products Limited — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0405686900258VC | Class B | Active |
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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 cddbadca-02fe-4965-a4f7-701a77bc2eac 61 fields · synced Jun 19, 2026