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Syphilis Rapid Test
EUDAMEDClass C (EU MDR)
Ref ISY-N401Ref ISY-N402B-40Ref ISY-N402J-25Ref ISY-N402B-25
Identity
- Trade Name
- Syphilis Rapid Test EUDAMED
- Device Name
- Syphilis Rapid Test EUDAMED
- Model / Reference
- ISY-N401 EUDAMEDISY-N402B-40 EUDAMEDISY-N402J-25 EUDAMEDISY-N402B-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983104463 EUDAMED06936983109499 EUDAMED06936983109598 EUDAMED06936983109482 EUDAMED
- Basic UDI-DI
- 6970277510000FXM EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Syphilis 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 | 6970277510000FXM | 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 (4)
- EUDAMED 9a91420d-f5a8-4c80-ae76-dc49db7e20ac 61 fields · synced Jul 23, 2026
- EUDAMED ff567dde-4db4-416d-b7a5-ba1581b0d0fd 61 fields · synced May 18, 2026
- EUDAMED 50a17994-fabb-4813-90d2-4d96a4be3075 61 fields · synced May 19, 2026
- EUDAMED 4e7cebd4-0b37-4ace-8598-d77d28d7d372 61 fields · synced May 19, 2026