Identity
- Trade Name
- JAY Shape EUDAMED
- Device Name
- Jay Back EUDAMED
- Model / Reference
- Shape EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050063057196 EUDAMED
- Basic UDI-DI
- 4050063jaybacksM7 EUDAMED
- Direct Marketing DI
- 04050063057196 EUDAMED
- EMDN Code
- Y180980 SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES 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
JAY Shape by Sunrise Medical GmbH — 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 | 4050063jaybacksM7 | Class I | Active |
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Manufacturer
- Manufacturer
- Sunrise Medical GmbH
- EUDAMED SRN
- DE-MF-000006320
Sources (1)
- EUDAMED b702a4d4-cd34-4464-aaf0-0b2be6ee273d 61 fields · synced Jun 17, 2026