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NeoPulse™ Disposable Pulse Oximeter Wrap - Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref N782Model NeoPulse™
Identity
- Trade Name
- NeoPulse™ Disposable Pulse Oximeter Wrap - Large EUDAMEDNeoPulse™ FDA UDI
- Generic Name
- Electrical cable/lead holder FDA UDI
- Device Name
- NeoPulse™ EUDAMEDThe NeoPulse is intended to hold a pulse oximeter sensor in place. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
- Model / Reference
- NeoPulse™ EUDAMEDN782 EUDAMEDLarge FDA UDI
- Description
- The NeoPulse is intended to hold a pulse oximeter sensor in place. It is intended for use on pediatric (neonates, infants and children) patients. FDA UDI
Identifiers
- Catalog Number
- N782 FDA UDI
- Primary DI / UDI-DI
- 10812594011501 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N78100NL EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- M03030199 ELASTIC FIXING BANDAGES - OTHER EUDAMED
- GMDN Term
- Electrical cable/lead holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
NeoPulse™ Disposable Pulse Oximeter Wrap - Large 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 | 081259401N78100NL | 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 9e7986a6-6881-4d99-995f-ef9c41f77f4b 61 fields · synced Jul 18, 2026
- FDA UDI 6cc23b3c-0340-48f7-9f57-e38f438d699c 34 fields · synced May 30, 2026