← Back to catalogue
NeoBridge® Umbilical Catheter Holder Small
EUDAMEDFDA UDIClass I (EU MDR)
Ref N701Model NeoBridge®
Identity
- Trade Name
- NeoBridge® Umbilical Catheter Holder Small EUDAMEDNeoBridge® FDA UDI
- Generic Name
- Wearable percutaneous catheter/tube holder FDA UDI
- Device Name
- NeoBridge® EUDAMEDThe NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- NeoBridge® EUDAMEDN701 EUDAMEDSmall FDA UDI
- Description
- The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N701 FDA UDI
- Primary DI / UDI-DI
- 10812594010269 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N70000LP EUDAMED
- FDA Product Code
- KMK FDA UDI
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
- GMDN Term
- Wearable percutaneous catheter/tube holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5210 FDA UDI
- Market of Registration
- Germany 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
NeoBridge® Umbilical Catheter Holder Small by Neotech Products LLC — 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 | 081259401N70000LP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 35eebb07-581d-464d-b859-764b1b92f08d 61 fields · synced Jul 18, 2026
- FDA UDI 0a6e250f-30f9-46c9-8396-acf14fd66e5a 34 fields · synced May 30, 2026