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Preformed Spasticity Splint RT/M
EUDAMEDClass I (EU MDR)
Ref TH1001-03Model TH1001
Identity
- Trade Name
- Preformed Spasticity Splint RT/M EUDAMED
- Device Name
- Preformed Spasticity Splint EUDAMED
- Model / Reference
- TH1001 EUDAMEDTH1001-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032900866 EUDAMED
- Basic UDI-DI
- 73400329TH100153 EUDAMED
- Direct Marketing DI
- 07340032900866 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Preformed Spasticity Splint RT/M by Mediroyal Nordic AB — 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 | 73400329TH100153 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 0f60c99c-3555-4456-a760-bbe7690e0a9f 61 fields · synced Jul 14, 2026