Identity
- Trade Name
- Rialto® Reformer EUDAMEDRialto® Reformer with Tower and Mat EUDAMED
- Device Name
- Reformer-Trapeze Combination (RTC) EUDAMED
- Model / Reference
- 16088 EUDAMED16487 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810052140308 EUDAMED00810052140544 EUDAMED
- Basic UDI-DI
- 0810052148000LS EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Rialto® Reformer by Balanced Body Inc — 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 | 0810052148000LS | Class I | Active |
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Manufacturer
- Manufacturer
- Balanced Body Inc
- EUDAMED SRN
- US-MF-000045340
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4edfb10b-2afa-4518-84bd-8be41bfd99bf 61 fields · synced Sep 17, 2026
- EUDAMED 126fa0ca-0ea4-4d3b-a3ba-7f8f81e3ce78 61 fields · synced May 19, 2026