Taloneras descanso, gel
EUDAMEDFDA UDIClass I (EU MDR)
by Prim, S.a.
Identity
- Trade Name
- Taloneras descanso, gel EUDAMEDComforgel FDA UDI
- Generic Name
- Foot friction/impact protector FDA UDI
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMEDRest heel pads, gel FDA UDI
- Model / Reference
- CG0501 EUDAMEDFDA UDI
- Description
- Rest heel pads, gel FDA UDI
Identifiers
- Catalog Number
- 736469 FDA UDI
- Primary DI / UDI-DI
- 08434048106554 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
- Foot friction/impact protector 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
Taloneras descanso, 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 a7a90d3a-fb2e-4e7d-8f33-f706412d006d 61 fields · synced Jun 19, 2026
- FDA UDI 4a0f24cf-d2b0-4b2c-bd0f-e233ee0f6ede 34 fields · synced May 29, 2026