Identity
- Trade Name
- NEO-prep™ EUDAMEDNEO-prep FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, silicone FDA UDI
- Device Name
- COMFIT™ EUDAMEDNEO-prep Neonatal Skin Prep Tabs - large FDA UDI
- Model / Reference
- 42-1820 EUDAMED44-8001 EUDAMEDFDA UDI
- Description
- NEO-prep Neonatal Skin Prep Tabs - large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937016987 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD009ZM EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Area/Surface Area — 1.66 Square inch FDA UDI
Category: Scar-management dressing, reusable
NEO-prep™ by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scar-management dressing, reusable.
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- THERAFOAM — BIODERMIS LLC · Class I
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 | 0888937TD009ZM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
- EUDAMED SRN
- US-MF-000002607
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 4cfb348c-81e9-4a52-b69d-149e1720e20e 61 fields · synced Jul 25, 2026
- FDA UDI a556c6ac-1e8a-4c46-b414-5e5b32e847ac 34 fields · synced May 30, 2026