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SPX Max Plus Reformer Bundle With High Precision Gearbar (Jet Black)
EUDAMEDClass I (EU MDR)
Ref ST-11108Ref ST-11118Ref ST-11087
Identity
- Trade Name
- SPX Max Plus Reformer Bundle With High Precision Gearbar (Jet Black) EUDAMEDBundle - SPX Max Plus (Jet Black) EUDAMEDBundle - SPX Max Reformer (Jet Black) EUDAMED
- Device Name
- REFORMER & VERTICAL FRAME EUDAMEDREFORMERS EUDAMED
- Model / Reference
- ST-11108 EUDAMEDST-11118 EUDAMEDST-11087 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650111081 EUDAMED00690650111180 EUDAMED00690650110879 EUDAMED
- Basic UDI-DI
- 690650REFORMERVERTFRAMEYZ EUDAMED690650REFORMERKA EUDAMED
- Direct Marketing DI
- 00690650111081 EUDAMED00690650111180 EUDAMED00690650110879 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
SPX Max Plus Reformer Bundle With High Precision Gearbar (Jet Black) 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 (4)
- EUDAMED 1a236cb0-17a8-4988-b361-0fef9518dc49 61 fields · synced Jul 19, 2026
- EUDAMED 9f38bf46-35f7-4a8a-80eb-b7ffccb9f916 61 fields · synced Jun 18, 2026
- EUDAMED 304ba8dd-aa67-424b-a646-ecc907d62a7d 61 fields · synced Jul 16, 2026
- EUDAMED f3e8dfb8-0508-4807-abba-d16aaac8fd60 61 fields · synced Jul 19, 2026