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Preformed Functional Splint RT/L
EUDAMEDClass I (EU MDR)
Ref TH1002-04Model TH1002
Identity
- Trade Name
- Preformed Functional Splint RT/L EUDAMED
- Device Name
- Preformed Functional Splint EUDAMED
- Model / Reference
- TH1002 EUDAMEDTH1002-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032900934 EUDAMED
- Basic UDI-DI
- 73400329TH100255 EUDAMED
- Direct Marketing DI
- 07340032900934 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 Functional Splint RT/L 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 | 73400329TH100255 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED bd8b2587-6e95-4b0d-93db-d373d0c70523 61 fields · synced Jul 11, 2026