Identity
- Trade Name
- EYETEC EUDAMEDKITPACK FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- PVA Instrument Wipe 3"x3"x2mm (Bulk) EUDAMEDPVA Instrument Wipe Bulk Packed Non-sterile - 300 Pieces 3"x3"x1mm FDA UDI
- Model / Reference
- PVA Instrument Wipes EUDAMED1-905 EUDAMEDFDA UDI
- Description
- PVA Instrument Wipe Bulk Packed Non-sterile - 300 Pieces 3"x3"x1mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056100712584 EUDAMEDFDA UDI
- Basic UDI-DI
- 506016501T1_02wipeDCBUX EUDAMED
- 510(k) Number
- K130117 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - 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
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Eyetec by Network Medical Products Limited — 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 | 506016501T1_02wipeDCBUX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Network Medical Products Limited
- EUDAMED SRN
- GB-MF-000025518
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 1a20d0ff-ae7e-4473-9b30-23c61e4a6d73 61 fields · synced May 30, 2026
- FDA UDI 8405068a-118b-4616-a01f-4397af0d426d 34 fields · synced May 30, 2026