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Theraplush Multisensory Therapeutic Weighted Blankets
EUDAMEDClass I (EU MDR)
Ref RL-11
Identity
- Trade Name
- Theraplush Multisensory Therapeutic Weighted Blankets EUDAMED
- Device Name
- Theraplush Multisensory Therapeutic Weighted Blankets EUDAMED
- Model / Reference
- RL-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62980432518604 EUDAMED
- Basic UDI-DI
- 6298043RL-11VE 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
Theraplush Multisensory Therapeutic Weighted Blankets 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 | 6298043RL-11VE | 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 d5fa74d0-1721-419d-b722-c025069e5ba7 61 fields · synced Jun 18, 2026