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Lower Extremity Tap (tone And Positioning) Splint
EUDAMEDClass I (EU MDR)
Ref 8570 BEI YBRef 8570 BEI YARef 8570 BEI AC
Identity
- Device Name
- LOWER EXTREMITY TAP (TONE AND POSITIONING) SPLINT EUDAMED
- Model / Reference
- 8570 BEI YB EUDAMED8570 BEI YA EUDAMED8570 BEI AC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914038208 EUDAMED00885914038192 EUDAMED00885914038215 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 (3)
- EUDAMED 28582d45-59a0-4715-aa31-59168d19e9a3 61 fields · synced Aug 4, 2026
- EUDAMED 267cac0b-1518-422d-a50b-70557340d652 61 fields · synced May 18, 2026
- EUDAMED f2191783-5810-4ac6-a108-b6a6eb375b08 61 fields · synced May 19, 2026