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Senti2
EUDAMEDClass IIa (EU MDR)
Ref SEN-FOT001Model 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 Ref SEN-FOT007Ref SEN-NAS001Model 188962 / 18-3362Ref SEN-COS134
by Aso Llc
Identity
- Trade Name
- Senti2 EUDAMED
- Device Name
- Non-Sterile Hydrocolloid Bandages EUDAMEDNasal Dilator Triple Bridge Tan P2S EUDAMED
- Model / Reference
- 40-3001/ 780349 / 40-3003 / 780351 / 40-3014 / 752825 / 40-3070 / 2003043 / 40-3071 / 2003041 / 40-3075 / 2003042 / 40-4013 / 752892 / 40-6001 / 781429 / 40-6003 / 781430 / 40-6013 / 781431 / 75-1623 / 781623 / 75-4331 / 754331 / 75-4378 / 754378 EUDAMEDSEN-FOT001 EUDAMEDSEN-FOT007 EUDAMED188962 / 18-3362 EUDAMEDSEN-NAS001 EUDAMEDSEN-COS134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436538553503 EUDAMED08436538553565 EUDAMED08436538552322 EUDAMED08436538552292 EUDAMED
- Basic UDI-DI
- 0017276M226M3 EUDAMED0017276188962S4 EUDAMED
- EMDN Code
- M04040301 HYDROCOLLOID DRESSINGS, NON-COMBINED EUDAMEDM0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Senti2 by Aso LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0017276M226M3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aso Llc
- EUDAMED SRN
- US-MF-000008641
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (4)
- EUDAMED 3b8b2a31-c845-43d1-8a16-cf9372fdc791 61 fields · synced Jul 30, 2026
- EUDAMED 21eb6566-7efe-498a-8d71-997c99a1b347 61 fields · synced May 16, 2026
- EUDAMED d4d170c3-4d3b-4fe9-84c9-de9d0b5f0760 61 fields · synced May 18, 2026
- EUDAMED 6e068ee6-75e5-46bc-b31d-11948a359bda 61 fields · synced May 19, 2026