Identity
- Trade Name
- TPHA, 200 tests EUDAMED
- Device Name
- TPHA, 200 tests EUDAMED
- Model / Reference
- 101-0177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-084360385505502EH EUDAMED
- Basic UDI-DI
- B-084360385505502EH EUDAMED
- EMDN Code
- W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
TPHA, 200 tests by Chronolab Systems, S.L. — 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-084360385505502EH | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chronolab Systems, S.L.
- EUDAMED SRN
- ES-MF-000017043
Sources (1)
- EUDAMED 13fbf99c-f884-4b23-ad10-43cf89443170 61 fields · synced Jun 18, 2026