Identity
- Trade Name
- Tamla-takalasta M EUDAMED
- Device Name
- Tamla Knee Splint EUDAMED
- Model / Reference
- Tamla Knee Splint EUDAMED1563840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430071530078 EUDAMED
- Basic UDI-DI
- 64300715315638TC9 EUDAMED
- Direct Marketing DI
- 06430071530078 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Category: Hand/finger splint, reusable
Tamla-takalasta M by Pedihealth Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand/finger splint, reusable.
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- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · Class I
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 | 64300715315638TC9 | Class I | Active |
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Manufacturer
- Manufacturer
- Pedihealth Oy
- EUDAMED SRN
- FI-MF-000000503
Sources (1)
- EUDAMED 787979cf-4265-49be-8bcc-9c6245d0aafa 61 fields · synced Jul 8, 2026