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NeoSeal® Nasal Prongs Seal Small
EUDAMEDFDA UDIClass I (EU MDR)
Ref N421Model NeoSeal®
Identity
- Trade Name
- NeoSeal® Nasal Prongs Seal Small EUDAMEDNeoSeal® FDA UDI
- Generic Name
- Patient tube cushion FDA UDI
- Device Name
- NeoSeal® EUDAMEDThe NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- NeoSeal® EUDAMEDN421 EUDAMEDSmall FDA UDI
- Description
- The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N421 FDA UDI
- Primary DI / UDI-DI
- 10812594011594 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N42000L4 EUDAMED
- FDA Product Code
- BXJ FDA UDI
- EMDN Code
- V080399 MEDICAL CUSHIONS - OTHER EUDAMED
- GMDN Term
- Patient tube cushion FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6225 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
NeoSeal® Nasal Prongs Seal 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 | 081259401N42000L4 | 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 a98c59f5-973f-49ff-8346-6118b71b54e8 61 fields · synced Jun 20, 2026
- FDA UDI 3eab6710-36a0-43f4-a19f-f4eaec06ba69 34 fields · synced May 30, 2026