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IMMULITE 2000 Ovomucoid Specific Allergen
EUDAMEDClass C (EU MDR)
Ref 10385733Model IVDR_67_LLB_DUB-C_C_REAG_Ovomucoid Specific Allergen
Identity
- Trade Name
- IMMULITE 2000 Ovomucoid Specific Allergen EUDAMED
- Device Name
- IVDR_67_LLB_DUB-C_C_REAG_Ovomucoid Specific Allergen EUDAMED
- Model / Reference
- IVDR_67_LLB_DUB-C_C_REAG_Ovomucoid Specific Allergen EUDAMED10385733 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414969381 EUDAMED
- Basic UDI-DI
- 0405686900558VT EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT EUDAMED
Classification
- Device Class
- Class C 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
New Device
No
EUDAMED
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
IMMULITE 2000 Ovomucoid Specific Allergen by Siemens Healthcare Diagnostics Products Limited — Class C — 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 | 0405686900558VT | Class C | 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 c33deded-052e-4e96-9e8b-4fc0a8a63984 61 fields · synced Oct 7, 2026