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S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine)
EUDAMEDClass IVD General (EU MDR)
Ref ISLC-125
Identity
- Trade Name
- S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine) EUDAMED
- Device Name
- Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette EUDAMED
- Model / Reference
- ISLC-125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970277514644 EUDAMED
- Basic UDI-DI
- B-06970277514644 EUDAMED
- EMDN Code
- W0105090199 BACTERIOLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
S. pneumoniae and L. pneumophila Combo Rapid Test Cassette (Urine) by Hangzhou Alltest Biotech.Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06970277514644 | Class IVD General | 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 (1)
- EUDAMED 59bd01af-1644-4042-97c9-ed854c48dd10 61 fields · synced Jul 24, 2026