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Footcare Device
EUDAMEDClass I (EU MDR)
Ref EVA1302Model BODY5017, BODY5018, BODY5044, BODY5004, BODY5047, BODY5089, BODY5028, BODY50118, BODY50050, BODY50132, BODY50095, BODY50113, BODY50079, BODY50139, BODY50129, BODY50133, BODY50137, BODY50136, BODY50143, BODY50143-1, etc
Identity
- Device Name
- Footcare Device EUDAMED
- Model / Reference
- BODY5017, BODY5018, BODY5044, BODY5004, BODY5047, BODY5089, BODY5028, BODY50118, BODY50050, BODY50132, BODY50095, BODY50113, BODY50079, BODY50139, BODY50129, BODY50133, BODY50137, BODY50136, BODY50143, BODY50143-1, etc EUDAMEDEVA1302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970434960826 EUDAMED
- Basic UDI-DI
- 697043496FD01G4 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Footcare Device by Dongguan Suscong Healthcare Co., Ltd — 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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- MEDI — MEDI MANUFACTURING, INC. · Class I
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 | 697043496FD01G4 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Suscong Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000041011
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 9f55cf11-b008-4cc8-8ec9-0b3b233218aa 61 fields · synced Jun 19, 2026