Ambu Neuroline Monopolar CableLength of leadwire: 76 cm (30")
FDA UDIEUDAMEDClass II (US FDA UDI)
by Ambu A/S
Identity
- Trade Name
- Ambu® Neuroline Monopolar EUDAMEDAmbu Neuroline Monopolar CableLength of leadwire: 76 cm (30") FDA UDINeuroline MonopolarNeurology Needle Electrodes FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDIElectromyographic needle electrode, single-use FDA UDI
- Device Name
- Ambu Neuroline Monopolar EUDAMEDLead Wire Length: 76 cm (30") Connector: 1.5 mm (DIN 42 802) FDA UDINeurology needle electrodes FDA UDI
- Model / Reference
- 74325-36/40 EUDAMEDFDA UDI74375-50/40 EUDAMEDFDA UDIAmbu Neuroline Monopolar EUDAMED1744 FDA UDI
- Description
- Lead Wire Length: 76 cm (30") Connector: 1.5 mm (DIN 42 802) FDA UDINeurology needle electrodes FDA UDI
Identifiers
- Catalog Number
- 1744 FDA UDI74325-36/40 FDA UDI74375-50/40 FDA UDI
- Primary DI / UDI-DI
- 05707480023769 EUDAMEDFDA UDI05707480023806 EUDAMEDFDA UDI05707480000074 FDA UDI
- Basic UDI-DI
- 570748030100804208W EUDAMED
- FDA Product Code
- IKD FDA UDIGXZ FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDIElectromyographic needle electrode, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1175 FDA UDI882.1350 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 76 Centimeter FDA UDILumen/Inner Diameter — 0.36 Millimeter FDA UDILength — 25 Centimeter FDA UDILumen/Inner Diameter — 0.5 Millimeter FDA UDILength — 75 Centimeter FDA UDI
Category: Analytical non-scalp cutaneous lead
Ambu Neuroline Monopolar CableLength of leadwire: 76 cm (30") by Ambu A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (5)
- FDA UDI 80f1e022-b204-43bc-8abf-f830c8a88b5b 37 fields · synced Jul 8, 2026
- FDA UDI 1c945d97-e6fb-4e9c-a6b4-ea298ddfbbbf 37 fields · synced May 30, 2026
- FDA UDI cdd0d0be-84c3-4217-b41f-c0f6fa18ddf6 37 fields · synced May 30, 2026
- EUDAMED b8648c97-b084-4e31-a33b-ef0843edf52a 61 fields · synced Jul 8, 2026
- EUDAMED 9014ed7e-9cad-41c7-8987-f12362cc67a8 61 fields · synced Jul 8, 2026