Identity
- Trade Name
- Baby Wells EUDAMED
- Device Name
- Manual Nasal Aspirator EUDAMED
- Model / Reference
- BN3 EUDAMEDBN305TP-SE01 EUDAMEDBN303 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 5600954025880 EUDAMED5600954000375 EUDAMED
- Basic UDI-DI
- 471989245BN3PH EUDAMED
- Direct Marketing DI
- 5600954025880 EUDAMED
- EMDN Code
- R05010399 MUCOSITY ASPIRATORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMEDPoland 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
Baby Wells by Acute Ideas Co., Ltd. — Class I — 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 | 471989245BN3PH | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acute Ideas Co., Ltd.
- EUDAMED SRN
- TW-MF-000025282
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED dc6b2e59-cb23-42da-83bb-9c89b8a89a01 61 fields · synced Aug 2, 2026
- EUDAMED 20ab3540-5284-499e-8b44-f570180dfd58 61 fields · synced May 18, 2026