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Non-invasive Preeclampsia Early Detection Kit (Reversible terminal termination …
EUDAMEDClass IVD General (EU MDR)
Ref S301Model 96 tests/kit
Identity
- Device Name
- Non-invasive Preeclampsia Early Detection Kit (Reversible terminal termination method) EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDS301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975585300002 EUDAMED
- Basic UDI-DI
- B-06975585300002 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Non-invasive Preeclampsia Early Detection Kit (Reversible terminal termination … by Ankang Euler Technology Co., LTD — Class IVD General — IVDD — listed in…
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-06975585300002 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Ankang Euler Technology Co., LTD
- EUDAMED SRN
- CN-MF-000027199
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9f671e49-c6f3-4586-9013-88db717c309c 61 fields · synced Jun 19, 2026