Identity
- Trade Name
- Bundle - SPX Max Plus Reformer w/Tall Box EUDAMED
- Device Name
- REFORMER & VERTICAL FRAME EUDAMED
- Model / Reference
- ST-11050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650110503 EUDAMED
- Basic UDI-DI
- 690650REFORMERVERTFRAMEYZ EUDAMED
- Direct Marketing DI
- 00690650110503 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 - SPX Max Plus Reformer w/Tall Box by Merrithew International 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 | 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 2556bf8c-471d-4484-8141-d77be7e6b3c1 61 fields · synced Jul 31, 2026
- EUDAMED 5b4b013d-38f9-4b07-bf00-2b476cb4b921 61 fields · synced Jul 31, 2026