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Tumble Forms Balance Beam
EUDAMEDClass I (EU MDR)
Ref 081027358Model EXERCISE THERAPY
Identity
- Trade Name
- TUMBLE FORMS BALANCE BEAM EUDAMED
- Device Name
- GROSS MOTOR AND SENSORY STIMULATION DEVICES EUDAMED
- Model / Reference
- EXERCISE THERAPY EUDAMED081027358 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914005309 EUDAMED
- Basic UDI-DI
- 08859140000000000000005KU EUDAMED
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Tumble Forms Balance Beam by Performance Health Supply, LLC — 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 | 08859140000000000000005KU | Class I | Active |
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Manufacturer
- Manufacturer
- Performance Health Supply, LLC
- EUDAMED SRN
- US-MF-000003318
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 4772a610-ab7a-472f-85c6-e6b0870d3c01 61 fields · synced Jun 19, 2026