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Preformed Functional Splint, perforated RT/S
EUDAMEDClass I (EU MDR)
Ref TH1004-2Model TH1004
Identity
- Trade Name
- Preformed Functional Splint, perforated RT/S EUDAMED
- Device Name
- Preformed Functional Splint, perforated EUDAMED
- Model / Reference
- TH1004 EUDAMEDTH1004-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340032901047 EUDAMED
- Basic UDI-DI
- 73400329TH100459 EUDAMED
- Direct Marketing DI
- 07340032901047 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, perforated RT/S 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 | 73400329TH100459 | Class I | Active |
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Manufacturer
- Manufacturer
- Mediroyal Nordic AB
- EUDAMED SRN
- SE-MF-000007821
Sources (1)
- EUDAMED 02f4ae33-f300-4108-8e1b-9a51ded4ab42 61 fields · synced Jul 28, 2026