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Vital Comfort
EUDAMEDClass I (EU MDR)
Ref N-300035Model Vital Comfort toe spreader, 3 pcs
Identity
- Trade Name
- Vital Comfort EUDAMED
- Device Name
- Vital Comfort toe spreader, 3 pcs EUDAMED
- Model / Reference
- Vital Comfort toe spreader, 3 pcs EUDAMEDN-300035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250007912257 EUDAMED
- Basic UDI-DI
- 4250007912257QN EUDAMED
- Direct Marketing DI
- 04250007912257 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Vital Comfort by Suzhou Sunmed 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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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 | 4250007912257QN | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Sunmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000010170
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8c57d149-a1b4-4b5d-9024-3c25cd7621e7 61 fields · synced Jun 19, 2026