Identity
- Trade Name
- STRAP4U ROUGE T1 EUDAMED
- Device Name
- STRAP4U EUDAMED
- Model / Reference
- S4U - R - T1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700110950250 EUDAMED
- Basic UDI-DI
- 3770011095STRAP_01ZW EUDAMED
- EMDN Code
- Y060603 FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Strap4u Rouge T1 by Creation Xxi — Class I — 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 | 3770011095STRAP_01ZW | Class I | Active |
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Manufacturer
- Manufacturer
- Creation Xxi
- EUDAMED SRN
- FR-MF-000012697
Sources (1)
- EUDAMED a5345679-6b0e-4e89-9626-d3956f0ab52a 61 fields · synced Jun 19, 2026