Identity
- Trade Name
- Bundle - Rehab V2 Max Plus Reformer EUDAMED
- Device Name
- REFORMER & VERTICAL FRAME EUDAMED
- Model / Reference
- ST-01085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650010858 EUDAMED
- Basic UDI-DI
- 690650REFORMERVERTFRAMEYZ EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDFrance 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
Bundle - Rehab V2 Max Plus Reformer by Merrithew International Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Rehab Reformers
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 | 690650REFORMERVERTFRAMEYZ | Class I | Active |
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Manufacturer
- Manufacturer
- Merrithew International Inc
- EUDAMED SRN
- CA-MF-000005225
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (2)
- EUDAMED 13e20b17-71dd-4412-8ad2-2f721b36e233 61 fields · synced Jul 23, 2026
- EUDAMED c7c0da6e-8bf0-41d0-bb0c-d7d3e6e1bc43 61 fields · synced Jul 23, 2026