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Rolyan Ball Hand Piece Skateboard Accessory - Right
EUDAMEDClass I (EU MDR)
Ref 081274208Model EXERCISE THERAPY
Identity
- Trade Name
- ROLYAN BALL HAND PIECE SKATEBOARD ACCESSORY - RIGHT EUDAMED
- Device Name
- SHOULDER AND ARM EXERCISE EUDAMED
- Model / Reference
- EXERCISE THERAPY EUDAMED081274208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00885914029749 EUDAMED
- Basic UDI-DI
- 08859140000000000000006KW EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER 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
Rolyan Ball Hand Piece Skateboard Accessory - Right 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 | 08859140000000000000006KW | 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 9512d879-4c8d-4cbf-b072-be4634b01fe6 61 fields · synced Jun 20, 2026