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Theophylline Determination Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass C (EU MDR)
Ref P11402Model 25 tests
Identity
- Trade Name
- Theophylline Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Device Name
- Theophylline Determination Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- 25 tests EUDAMEDP11402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942293580583 EUDAMED
- Basic UDI-DI
- 697518250P1140262 EUDAMED
- Direct Marketing DI
- 06942293580583 EUDAMED
- EMDN Code
- W0102080402 THEOPHYLLINE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
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
Yes
EUDAMED
Theophylline Determination Kit (Fluorescence Immunochromatographic Assay) by Beijing Diagreat Biotechnologies Co., Ltd. — Class C — IVDR — listed in EUDAMED
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 | 697518250P1140262 | Class C | Active |
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Manufacturer
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000019511
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a1cbb895-5fae-41c0-847f-b53d88484aaf 61 fields · synced Oct 6, 2026