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Combined Diagnostic Kit for Human 1295 Genes Mutation (Reversible terminal term…
EUDAMEDClass IVD General (EU MDR)
Ref S305Model 96 tests/kit
Identity
- Device Name
- Combined Diagnostic Kit for Human 1295 Genes Mutation (Reversible terminal termination method) EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDS305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975585300040 EUDAMED
- Basic UDI-DI
- B-06975585300040 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
Combined Diagnostic Kit for Human 1295 Genes Mutation (Reversible terminal term… 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-06975585300040 | 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 6ae67f2c-0400-495b-b279-cbf364c5e605 61 fields · synced Jul 15, 2026