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Legionella pneumophila Rapid Test
EUDAMEDClass C (EU MDR)
Ref ILEG-N102B-10Ref ILEG-N102-25
Identity
- Trade Name
- Legionella pneumophila Rapid Test EUDAMED
- Device Name
- Legionella pneumophila Rapid Test EUDAMED
- Model / Reference
- ILEG-N102B-10 EUDAMEDILEG-N102-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983115674 EUDAMED06936983104807 EUDAMED
- Basic UDI-DI
- 6970277510001BXG EUDAMED
- EMDN Code
- W0105090108 LEGIONELLA - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland 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
Legionella pneumophila Rapid Test by Hangzhou Alltest Biotech.Co., Ltd. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 6970277510001BXG | Class C | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED c8b88d34-6acb-43b7-8f85-6a7c9fc038fe 61 fields · synced Jul 13, 2026
- EUDAMED 63d67974-ff2f-4017-b37e-18ffa3bb28e4 61 fields · synced May 16, 2026