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Footcare Device
EUDAMEDClass I (EU MDR)
Ref EVA0323Model BODY5017, BODY5018, BODY5044, BODY5004, BODY5047, BODY5089, BODY5028, BODY50118, BODY50050, BODY50132, BODY50095, BODY50113, BODY50079, BODY50139, BODY50129, BODY50133, BODY50137, BODY50136, BODY50143, BODY50143-1, etcRef C-PFM0108Ref BODY5017Ref PFM0117-1Ref C-PFM0120Ref C-EVA0315Ref C-PFM0117 SW
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 EUDAMEDEVA0323 EUDAMEDC-PFM0108 EUDAMEDBODY5017 EUDAMEDPFM0117-1 EUDAMEDC-PFM0120 EUDAMEDC-EVA0315 EUDAMEDC-PFM0117 SW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970434960918 EUDAMED06970434960888 EUDAMED06970434960017 EUDAMED06970434960857 EUDAMED06970434960895 EUDAMED06970434960833 EUDAMED06970434960864 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
Footcare Device by Dongguan Suscong Healthcare Co., Ltd — 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 | 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 (7)
- EUDAMED c0a938a6-2de0-4adf-9974-2b468e488007 61 fields · synced Oct 6, 2026
- EUDAMED 9f0fd09e-6376-4d6b-84a9-c4ef2877ee1f 61 fields · synced May 16, 2026
- EUDAMED 2689039e-2cfe-43db-b06f-a6e153a10857 61 fields · synced May 18, 2026
- EUDAMED c98c93d7-bc5a-4b74-bcba-958ccbbcfd16 61 fields · synced May 18, 2026
- EUDAMED 11460c4b-776d-49f1-a5ec-d57ea20b7f44 61 fields · synced May 18, 2026
- EUDAMED 9f151175-bd5d-4a4e-84fd-950f3769c0f6 61 fields · synced May 18, 2026
- EUDAMED 3787dd52-4606-48b6-9971-ad2736c564fe 61 fields · synced May 19, 2026