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SPINEFITTER by Sissel ® Pink Hero Editon
EUDAMEDClass I (EU MDR)
Ref 800826 / 162.314Model Ball
by SISSEL GmbH
Identity
- Trade Name
- SPINEFITTER by Sissel ® Pink Hero Editon EUDAMED
- Model / Reference
- Ball EUDAMED800826 / 162.314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250694718101 EUDAMED
- Basic UDI-DI
- 42506947Z1206023R EUDAMED
- Direct Marketing DI
- 04250694718101 EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT 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 ® Pink Hero Editon by SISSEL GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Pink Hero Edition
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 | 42506947Z1206023R | Class I | Active |
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Manufacturer
- Manufacturer
- SISSEL GmbH
- EUDAMED SRN
- DE-MF-000007624
Sources (1)
- EUDAMED 09115ef0-e197-45d8-bfd7-573bd5e80590 61 fields · synced Oct 6, 2026