Miniplantillas extrafinas antideslizantes, Gel
EUDAMEDFDA UDIClass I (EU MDR)
by Prim, S.a.
Identity
- Trade Name
- Miniplantillas extrafinas antideslizantes, Gel EUDAMEDComforgel FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMEDExtra-thin non-slip mini-insoles, Gel FDA UDI
- Model / Reference
- CG0401 EUDAMEDFDA UDI
- Description
- Extra-thin non-slip mini-insoles, Gel FDA UDI
Identifiers
- Catalog Number
- 736448 FDA UDI
- Primary DI / UDI-DI
- 08434048106349 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
- Orthotic insole, prefabricated, non-antimicrobial 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
Miniplantillas extrafinas antideslizantes, Gel 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 e7ee7b23-396b-4633-a41c-1c512b271c8c 61 fields · synced Jul 13, 2026
- FDA UDI 9e471bb4-f503-4431-8943-e1e4b8c16cfb 34 fields · synced May 30, 2026