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NeoBridge® Umbilical Catheter Holder Micro
EUDAMEDFDA UDIClass I (EU MDR)
Ref N700Model NeoBridge®
Identity
- Trade Name
- NeoBridge® Umbilical Catheter Holder Micro 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® EUDAMEDN700 EUDAMEDMico 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
- N700 FDA UDI
- Primary DI / UDI-DI
- 10812594010177 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 Micro 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 |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7d8ab645-6bc1-46d5-88b7-b5c39aa78754 61 fields · synced Jul 10, 2026
- FDA UDI 7e16fb47-80d3-42e7-a761-954624023c5e 34 fields · synced May 30, 2026