Identity
- Device Name
- FOOT COMPRESSION SLEEVE - 20-30 mmHg EUDAMED
- Model / Reference
- 850054396709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850054396709 EUDAMED
- Basic UDI-DI
- 0850054396FCS30S3 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
FOOT COMPRESSION SLEEVE - 20-30 mmHg by KSY Goods Supply LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 0850054396FCS30S3 | 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 a589f604-fb44-4ba0-9653-59f8c7d4530f 61 fields · synced Jul 21, 2026