Identity
- Trade Name
- Neuropen FDA UDI
- Generic Name
- Pressure algometer/aesthesiometer, mechanical FDA UDI
- Device Name
- Non sterile, sensory neuropathy screening device FDA UDI
- Model / Reference
- NT0100 FDA UDI
- Description
- Non sterile, sensory neuropathy screening device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384700100018 FDA UDI
- FDA Product Code
- GXB FDA UDI
- GMDN Term
- Pressure algometer/aesthesiometer, mechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pressure algometer/aesthesiometer, mechanical
Neuropen by Owen Mumford Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Pressure algometer/aesthesiometer, mechanical.
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- Neuropen Monofilaments 10g — OWEN MUMFORD LIMITED · Class I
- Neurotips — OWEN MUMFORD LIMITED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Owen Mumford Limited
Sources (1)
- FDA UDI 740713d5-5237-42a2-be4e-7f02a5fe820c 35 fields · synced May 30, 2026