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Footcare Device
EUDAMEDClass I (EU MDR)
Ref C-PFM01035Model 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 EUDAMEDC-PFM01035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970434960925 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 (1)
- EUDAMED 1c1a9485-33f4-4678-a5a8-fd7eea9c7556 61 fields · synced Jun 17, 2026