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SpineMED
EUDAMEDClass IIa (EU MDR)
Ref S200ECModel S200E/S200EC/S200U/S200UC/S200B/S200C
Identity
- Trade Name
- SpineMED EUDAMED
- Device Name
- SpineMED Decompression System EUDAMED
- Model / Reference
- S200E/S200EC/S200U/S200UC/S200B/S200C EUDAMEDS200EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M767S200EC1 EUDAMED
- Basic UDI-DI
- ++M767S200FF EUDAMED
- Direct Marketing DI
- +M767S200EC1 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
SpineMED by Universal Pain Technology Canada Inc. — Class IIa — 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 | ++M767S200FF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Universal Pain Technology Canada Inc.
- EUDAMED SRN
- CA-MF-000001267
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED bed30c6c-ac22-4042-9042-bd08b9d4a22e 61 fields · synced May 29, 2026