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V2 Max Plus™ Reformer (ONYX) Bundle with High Precision Gearbar
EUDAMEDClass I (EU MDR)
Ref ST-11100
Identity
- Trade Name
- V2 Max Plus™ Reformer (ONYX) Bundle with High Precision Gearbar EUDAMED
- Device Name
- REFORMER & VERTICAL FRAME EUDAMED
- Model / Reference
- ST-11100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650111005 EUDAMED
- Basic UDI-DI
- 690650REFORMERVERTFRAMEYZ EUDAMED
- Direct Marketing DI
- 00690650111005 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
V2 Max Plus™ Reformer (ONYX) Bundle with High Precision Gearbar by Merrithew International Inc — Class I — MDR — listed in EUDAMED
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 (2)
- EUDAMED 143ee33b-dc47-4374-b5ec-18d8334f5c48 61 fields · synced Jul 26, 2026
- EUDAMED 15995317-a7e8-4941-ba81-05647c5cf2ed 61 fields · synced Jul 26, 2026