Identity
- Trade Name
- Prisma Long Black, Right XS EUDAMED
- Device Name
- Hand EUDAMED
- Model / Reference
- 7080-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07340202107514 EUDAMED
- Basic UDI-DI
- 734020216M6 EUDAMED
- EMDN Code
- Y060606 HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Prisma Long Black, Right XS by Catell AB — 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 | 734020216M6 | Class I | Active |
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Manufacturer
- Manufacturer
- Catell AB
- EUDAMED SRN
- SE-MF-000000726
Sources (1)
- EUDAMED b8f257b4-f04e-412d-9928-85323db25805 61 fields · synced Jun 19, 2026