← Back to catalogue
SPINEFITTER by SISSEL® Linum Pro
EUDAMEDClass I (EU MDR)
Ref 162.320Model SISSEL® THERM
by SISSEL GmbH
Identity
- Trade Name
- SPINEFITTER by SISSEL® Linum Pro EUDAMED
- Device Name
- SISSEL® THERM tri-sectional EUDAMED
- Model / Reference
- SISSEL® THERM EUDAMED162.320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250694717180 EUDAMED
- Basic UDI-DI
- 42506947M90019N EUDAMED
- Direct Marketing DI
- 04250694717180 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I 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
SPINEFITTER by SISSEL® Linum Pro by SISSEL GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: SPINEFITTER SYSTEM
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 | 42506947M90019N | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SISSEL GmbH
- EUDAMED SRN
- DE-MF-000007624
Sources (1)
- EUDAMED df7e74e5-2e37-4349-9542-77e7d1982bdd 61 fields · synced Jul 9, 2026