Identity
- Trade Name
- Multisensory Comfort Toy “Poppet” EUDAMED
- Device Name
- Multisensory Comfort Toy “Poppet” EUDAMED
- Model / Reference
- SWT-55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62980432518840 EUDAMED
- Basic UDI-DI
- 6298043SWT-553Y 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
Multisensory Comfort Toy “Poppet” 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 | 6298043SWT-553Y | 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 60a2d7d2-13d8-4a14-9ba9-08beffa30665 61 fields · synced Jul 10, 2026