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Lámina fieltro adhesiva recortable
EUDAMEDFDA UDIClass I (EU MDR)
Ref CC249
by Prim, S.a.
Identity
- Trade Name
- Lámina fieltro adhesiva recortable EUDAMEDComforsil FDA UDI
- Generic Name
- Orthotic insole, prefabricated, non-antimicrobial FDA UDI
- Device Name
- Ortesis Podológicas/Podiatry Orthoses EUDAMEDCuttable adhesive felt sheet FDA UDI
- Model / Reference
- CC249 EUDAMEDFDA UDI
- Description
- Cuttable adhesive felt sheet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08431082070896 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Lámina fieltro adhesiva recortable by Prim S.a. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 36ff2bc1-cb4d-49cd-8777-96c751119d90 61 fields · synced Jul 12, 2026
- FDA UDI 82c3903c-b56b-4408-af29-b64bde1d9cd0 33 fields · synced May 30, 2026