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V2 Max Plus™ Reformer (ONYX) Bundle (with reg. Gearbar)
EUDAMEDClass I (EU MDR)
Ref ST-11106
Identity
- Trade Name
- V2 Max Plus™ Reformer (ONYX) Bundle (with reg. Gearbar) EUDAMED
- Device Name
- REFORMER & VERTICAL FRAME EUDAMED
- Model / Reference
- ST-11106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650111067 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 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
V2 Max Plus™ Reformer (ONYX) Bundle (with reg. Gearbar) by Merrithew International Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Free Jumpboard with select 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 (1)
- EUDAMED 29e1e154-cb8e-4196-a60e-02a03ea9511d 61 fields · synced Jun 20, 2026