Identity
- Device Name
- ELBOW COMPRESSION SLEEVE EUDAMED
- Model / Reference
- 850054396723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850054396723 EUDAMED
- Basic UDI-DI
- 0850054396ECS20RM EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Elbow Compression Sleeve by KSY Goods Supply LLC — 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 | 0850054396ECS20RM | Class I | Active |
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Manufacturer
- Manufacturer
- KSY Goods Supply LLC
- EUDAMED SRN
- US-MF-000050622
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 43d93869-06c3-4455-bd68-3e9a4b73cbc6 61 fields · synced Jun 19, 2026