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Artron One Step Treponema Pallidum (TP) Antibody Test
EUDAMEDClass IVD General (EU MDR)
Ref A02-09-213Model Strip
Identity
- Trade Name
- Artron One Step Treponema Pallidum (TP) Antibody Test EUDAMED
- Device Name
- Treponema Pallidum (TP) Antibody Test EUDAMED
- Model / Reference
- Strip EUDAMEDA02-09-213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347561109 EUDAMED
- Basic UDI-DI
- B-00628347561109 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Artron One Step Treponema Pallidum (TP) Antibody Test by Artron Laboratories Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-00628347561109 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 6b79549f-be46-48e3-9358-8ca1f8a23a0e 61 fields · synced Jun 19, 2026