Identity
- Trade Name
- EPSIMED FDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Device Name
- EPSIMED NT- 100 Neuromuscular Transmission Monitor FDA UDI
- Model / Reference
- NT-100 FDA UDI
- Description
- EPSIMED NT- 100 Neuromuscular Transmission Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04255629200904 FDA UDI
- 510(k) Number
- K212434 FDA UDI
- FDA Product Code
- KOI FDA UDI
- GMDN Term
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2775 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Block-monitoring peripheral nerve electrical stimulation system
Epsimed by Epsimed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Block-monitoring peripheral nerve electrical stimulation system.
- AincA® — Anesthesia Associates, Inc. · Class II
- TetraSens Pediatric — Senzime AB (Publ.) · Class II
- SunMed — SunMed · Class II
- TetraSens — Senzime AB (Publ.) · Class II
- AincA® — Anesthesia Associates, Inc. · Class II
- iTOF — NERBIO PRIVATE LIMITED · Class II
- SunMed — SunMed · Class II
- Infinity Trident Pod System — Draeger Medical Systems, Inc. · Class II
Cleared under the same submission
K212434 also covers:
- Eye adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Eye adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Hand adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Hand adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IV-pole holder TOF3D Variant A - Premium — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IV-pole holder TOF3D Variant A - Premium — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IV-pole holder TOF3D Variant B - Standard — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- TOF3D - Neuromuscular Transmission Monitor — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Temperature sensor TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Temperature sensor TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Thumb adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Thumb adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epsimed Llc
Sources (1)
- FDA UDI 82adefcb-3717-4b0f-b600-7e4c4acc8299 34 fields · synced May 30, 2026