Identity
- Trade Name
- Extended NTM EUDAMED
- Device Name
- Extended NTM EUDAMED
- Model / Reference
- M221118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972698600446 EUDAMED
- Basic UDI-DI
- 697269860NTM001VB EUDAMED
- Direct Marketing DI
- 16972698600446 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
Extended NTM by Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. — Class A — 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 | 697269860NTM001VB | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000013495
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED dfcc2d4f-cdd6-4d72-b1d4-12d3f9419cf3 61 fields · synced Jun 17, 2026