Identity
- Trade Name
- TOF3D - Neuromuscular Transmission Monitor FDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Model / Reference
- 2510091 FDA UDI
Identifiers
- Catalog Number
- 2510091 FDA UDI
- Primary DI / UDI-DI
- EMIP25100910 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
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
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
TOF3D - Neuromuscular Transmission Monitor by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K212434 also covers:
- EPSIMED — EPSIMED LLC
- 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
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
Sources (2)
- FDA UDI 0f03f13a-dd27-4644-9857-bee5ea329380 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026