Separador de dedos, extrafinos, silicona L
EUDAMEDFDA UDIClass I (EU MDR)
by Prim, S.a.
Identity
- Trade Name
- Separador de dedos, extrafinos, silicona L EUDAMEDComforsil FDA UDI
- Generic Name
- Toe separator FDA UDI
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMEDToe separator, extra fine, silicone FDA UDI
- Model / Reference
- CC206L EUDAMEDFDA UDI
- Description
- Toe separator, extra fine, silicone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08431082070834 EUDAMEDFDA UDI
- Basic UDI-DI
- 843404825PRODUCTOSPIEV7 EUDAMED
- FDA Product Code
- KYS FDA UDI
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
- GMDN Term
- Toe separator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6280 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthotic insole, prefabricated, non-antimicrobial
Separador de dedos, extrafinos, silicona L by Prim S.a. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 843404825PRODUCTOSPIEV7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prim, S.a.
- EUDAMED SRN
- ES-MF-000004651
Sources (2)
- EUDAMED fda32e6d-578f-4b77-92b8-8bd20341b8cd 61 fields · synced Jun 18, 2026
- FDA UDI 3e6774c7-9d4a-44a3-9a3d-b7c410de1873 33 fields · synced May 30, 2026