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S. pneumoniae Antigen Rapid Test
EUDAMEDClass C (EU MDR)
Ref ISP-N102-25Ref ISP-N102B-25Ref ISP-N102B-10Ref ISP-N102J-25Ref ISP-N102-10Ref ISP-N102J-10
Identity
- Trade Name
- S. pneumoniae Antigen Rapid Test EUDAMED
- Device Name
- S. pneumoniae Antigen Rapid Test EUDAMED
- Model / Reference
- ISP-N102-25 EUDAMEDISP-N102B-25 EUDAMEDISP-N102B-10 EUDAMEDISP-N102J-25 EUDAMEDISP-N102-10 EUDAMEDISP-N102J-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983104982 EUDAMED06936983115827 EUDAMED06936983115810 EUDAMED06936983116190 EUDAMED06936983104975 EUDAMED06936983116183 EUDAMED
- Basic UDI-DI
- 6970277510001DXL EUDAMED
- EMDN Code
- W0105090109 STREP. PNEUMONIAE - 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
S. pneumoniae Antigen 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 | 6970277510001DXL | 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 (6)
- EUDAMED e9e6fc7f-8899-49f4-a338-93937ee9c88e 61 fields · synced Oct 6, 2026
- EUDAMED 18f1d65f-29e7-486a-ba85-0bd157c9d343 61 fields · synced May 17, 2026
- EUDAMED 2a62210e-6d17-447c-a5b1-90c6d62e3ecb 61 fields · synced May 17, 2026
- EUDAMED 4a8a3989-093f-41fd-873e-89a9b2121f85 61 fields · synced May 18, 2026
- EUDAMED 90cb7753-6de5-4b3f-91f8-bb83e67a9f54 61 fields · synced May 18, 2026
- EUDAMED 7cd45e3f-8e5d-4970-a6c8-1b830e6e18bf 61 fields · synced May 19, 2026