← Back to catalogue
Acmex Treponema Pallidum (TP) Antibody Test
EUDAMEDClass C (EU MDR)
Ref AM02-09-322PModel Cassette
Identity
- Trade Name
- Acmex Treponema Pallidum (TP) Antibody Test EUDAMED
- Device Name
- Syphilis Test EUDAMED
- Model / Reference
- Cassette EUDAMEDAM02-09-322P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00628347561093 EUDAMED
- Basic UDI-DI
- 62834756AL02090279 EUDAMED
- EMDN Code
- W0105090105 SYPHILIS - RT & POC EUDAMED
Classification
- Device Class
- Class C 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Acmex Treponema Pallidum (TP) Antibody Test by Artron Laboratories Inc. — 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 | 62834756AL02090279 | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- EUDAMED SRN
- CA-MF-000028974
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 98847249-048f-4f92-99dd-02e6d83be956 61 fields · synced Jun 20, 2026