Identity
- Trade Name
- Archcare Supports EUDAMED
- Device Name
- FOOT CUSHION EUDAMED
- Model / Reference
- 353-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719884891197 EUDAMED
- Basic UDI-DI
- 471988489CL106GS EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Archcare Supports by Welsheng Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471988489CL106GS | Class I | Active |
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Manufacturer
- Manufacturer
- Welsheng Corp.
- EUDAMED SRN
- TW-MF-000005197
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 29ed3629-5d67-42da-883c-7a5c22e59c62 61 fields · synced Oct 6, 2026