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Bundle - SPX Max Reformer w/Tall Box
EUDAMEDClass I (EU MDR)
Ref https://www.merrithew.com/shop/ProductDetail/ST11049_Spx-Max-Reformer-Bundle-With-Tall-Box
Identity
- Trade Name
- Bundle - SPX Max Reformer w/Tall Box EUDAMED
- Device Name
- REFORMERS EUDAMED
- Model / Reference
- https://www.merrithew.com/shop/ProductDetail/ST11049_Spx-Max-Reformer-Bundle-With-Tall-Box EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00690650110497 EUDAMED
- Basic UDI-DI
- 690650REFORMERKA 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
Bundle - SPX Max 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 | 690650REFORMERKA | 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 664be4ea-3ef5-412e-97ba-8a63ef6983e7 61 fields · synced Jul 21, 2026