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SpineMED
EUDAMEDClass IIa (EU MDR)
Ref S200CModel S200E/S200EC/S200U/S200UC/S200B/S200CRef S200ERef S200U
Identity
- Trade Name
- SpineMED EUDAMED
- Device Name
- SpineMED Decompression System EUDAMED
- Model / Reference
- S200E/S200EC/S200U/S200UC/S200B/S200C EUDAMEDS200C EUDAMEDS200E EUDAMEDS200U EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M767S200C1 EUDAMED+M767S200E1 EUDAMED+M767S200U1 EUDAMED
- Basic UDI-DI
- ++M767S200FF EUDAMED
- Direct Marketing DI
- +M767S200C1 EUDAMED+M767S200E1 EUDAMED+M767S200U1 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDAustria 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 (3)
- EUDAMED 7cd99b30-2291-4465-8443-65f27c217e17 61 fields · synced Jul 25, 2026
- EUDAMED b4079376-7adf-4828-9cce-21ca4192d41d 61 fields · synced May 18, 2026
- EUDAMED db7c5282-bd9b-40ee-ba59-8aac53396afe 61 fields · synced May 19, 2026