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Eco Supergel
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 0010171Model ULTRASOUND GEL
Identity
- Trade Name
- ECO SUPERGEL X ULTRASOUNDS 260 G EUDAMEDECO SUPERGEL FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- ULTRASOUND TRANSMISSION GEL 260 GR. FDA UDI
- Model / Reference
- ULTRASOUND GEL EUDAMEDFDA UDI0010171 EUDAMED
- Description
- ULTRASOUND TRANSMISSION GEL 260 GR. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057733230084 EUDAMEDFDA UDI
- Basic UDI-DI
- 8059170GC001NG EUDAMED
- 510(k) Number
- K101429 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
Eco Supergel by Ceracarta Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Skin topical coupling gel.
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Cleared under the same submission
K101429 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ceracarta Spa
Sources (2)
- FDA UDI 6c7e6453-3f51-4e26-bb54-c5edf3ef98ef 34 fields · synced Jul 19, 2026
- EUDAMED 39c7509e-798f-46de-89a8-c8d559deb981 61 fields · synced Jul 19, 2026