Identity
- Trade Name
- BABY WELLS EUDAMED
- Device Name
- Manual Nasal Aspirator EUDAMED
- Model / Reference
- BN3 EUDAMEDBN303TP-SE01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 5600954004304 EUDAMED
- Basic UDI-DI
- 471989245BN3PH EUDAMED
- Unit of Use DI
- BOX EUDAMED
- EMDN Code
- R05010399 MUCOSITY ASPIRATORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 |
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Manufacturer
- Manufacturer
- Acute Ideas Co., Ltd.
- EUDAMED SRN
- TW-MF-000025282
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED a24b56ce-c2cd-4f12-981f-220abd778e89 61 fields · synced Jun 18, 2026