Identity
- Trade Name
- Cenefom EUDAMEDFDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- Ophthalmic Sponge EUDAMEDWipe FDA UDI
- Model / Reference
- OP-IW01 EUDAMEDFDA UDI
- Description
- Wipe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711552929768 EUDAMED04711552929775 FDA UDI
- Basic UDI-DI
- 471155292OPT6 EUDAMED
- Direct Marketing DI
- 04711552929768 EUDAMED
- 510(k) Number
- K082460 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- M040399 OPHTHALMIC DRESSINGS - OTHER EUDAMED
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Cenefom by Cenefom Corp. — 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 | 471155292OPT6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cenefom Corp.
- EUDAMED SRN
- TW-MF-000012190
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 64ec13b9-41c6-4bf3-9de7-e64548eb4ab4 61 fields · synced Jul 8, 2026
- FDA UDI b4362ea2-8482-451b-8b6b-4965f1a6ecbf 34 fields · synced May 30, 2026