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SISSEL® FITBAND ESSENTIAL blue
EUDAMEDClass I (EU MDR)
Ref 163.104Model Fitband
by SISSEL GmbH
Identity
- Trade Name
- SISSEL® FITBAND ESSENTIAL blue EUDAMED
- Model / Reference
- Fitband EUDAMED163.104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250694703145 EUDAMED
- Basic UDI-DI
- 42506947Y0504CS EUDAMED
- Direct Marketing DI
- 04250694703145 EUDAMED
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION 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
Category: Rubber dam, Hevea-latex
SISSEL® FITBAND ESSENTIAL blue by SISSEL GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rubber dam, Hevea-latex.
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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 | 42506947Y0504CS | Class I | Active |
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Manufacturer
- Manufacturer
- SISSEL GmbH
- EUDAMED SRN
- DE-MF-000007624
Sources (1)
- EUDAMED 438e683a-3ec5-4d43-b0a1-92c4f4784773 61 fields · synced Jun 19, 2026