Identity
- Trade Name
- Sensory Pillow, Bee EUDAMED
- Device Name
- Sensory Pillow, Bee EUDAMED
- Model / Reference
- SWT-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 48434640004614 EUDAMED
- Basic UDI-DI
- 4843464SWT-202Y EUDAMED
- EMDN Code
- N01028099 NEUROLOGICAL PHYSIOTHERAPY DEVICES - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Sensory Pillow, Bee by Theraplush Lab Srl — 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 | 4843464SWT-202Y | Class I | Active |
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Manufacturer
- Manufacturer
- Theraplush Lab Srl
- EUDAMED SRN
- MD-MF-000048616
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED ef7d4088-1e23-4d83-8a3e-dda0a13bd948 61 fields · synced Jun 17, 2026