← Back to catalogue
ONE STEP Pregnancy (hCG) Test
EUDAMEDClass IVD General (EU MDR)
Ref ITP04002-DS50Model ITP04002
Identity
- Trade Name
- ONE STEP Pregnancy (hCG) Test EUDAMED
- Device Name
- ONE STEP Pregnancy (hCG) Test EUDAMED
- Model / Reference
- ITP04002 EUDAMEDITP04002-DS50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936155803484 EUDAMED
- Basic UDI-DI
- B-06936155803484 EUDAMED
- EMDN Code
- W0102160302 HCG - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
ONE STEP Pregnancy (hCG) Test by InTec PRODUCTS, 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-06936155803484 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- InTec PRODUCTS, INC.
- EUDAMED SRN
- CN-MF-000023625
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED f15674dc-8fef-47ef-8ec1-c9201fe05e5c 61 fields · synced Jul 9, 2026