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Lower Extremity Tap (tone And Positioning) Splint
EUDAMEDClass I (EU MDR)
Ref 8570 BEI AD
Identity
- Device Name
- LOWER EXTREMITY TAP (TONE AND POSITIONING) SPLINT EUDAMED
- Model / Reference
- 8570 BEI AD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914038222 EUDAMED
- Basic UDI-DI
- 7631898570D5 EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Lower Extremity Tap (tone And Positioning) Splint by Elastic Therapy — 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 | 7631898570D5 | Class I | Active |
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Manufacturer
- Manufacturer
- Elastic Therapy
- EUDAMED SRN
- US-MF-000021563
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 177d0c8a-8211-4b1a-be35-914f3c1b3922 61 fields · synced Jun 20, 2026